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AUSTEDO XR deutetrabenazine 48 mg Tablet, Film Coated, Extended Release, 30-count — NDC 68546-0476-56 package photo

AUSTEDO XR deutetrabenazine 48 mg Tablet, Film Coated, Extended Release, 30-count

by Teva Neuroscience, Inc. · 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-476-56)
NDC 68546-0476-56
🏷️ FDA NDC (as labeled) 68546-476-56 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 68546-476-56
Product NDC 68546-476
11-digit billing NDC 68546047656
NCPDP billing unit EA — each (per item)
RxCUI 1876910, 1876916, 1876918, 1876920, 1876922, 1876924, 2281114, 2281115,
UNII P341G6W9NB
UPC 0368546172606, 0368546170602, 0368546171609
Application # NDA216354
SPL Set ID 7ea3c60a-45c7-44cc-afc2-d87fa53993c0
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-29
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance DEUTETRABENAZINE
GPI-14 62380030007550
GCN Seq No 086153
GCN 55822
HICL code 044192
Ingredient (HICL) Deutetrabenazine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6L
Therapeutic class — specific (HIC3) Drugs To Treat Movement Disorders
AHFS code 28:56.00.00
AHFS class Vesicular Monoamine Transport2 Inhibitor
FDB label name AUSTEDO XR 48 MG TABLET
FDB brand name Austedo Xr
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68546-476-56 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68546-0476-56. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other nervous system drugs class.

Drug family (ATC) Other nervous system drugs
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTeva Neuroscience, Inc.
Application holderTEVA NEUROSCIENCE INC
FDA applicationNDA216354 (NDA)
Labeler code68546
First marketedMay 2024
Product typeHuman Prescription Drug
Portfolio17 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name AUSTEDO XR 48 MG TABLET Ingredient Deutetrabenazine
📖 What it is MedlinePlus · NLM

Deutetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). It is also used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). Deutetrabenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works by changing the activity of certain natural substances in the brain that affect nerves and muscles.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps control the involuntary, uncontrolled movements that come with Huntington's disease (called chorea) or that develop after long-term use of certain psychiatric medications...
  • What exactly does deutetrabenazine do — why did my doctor prescribe it?
  • Yes, and it's different for each one. Austedo XR (the once-daily extended-release tablet) can be taken with or without food — food doesn't affect how much of the drug gets into you...
  • Does it matter whether I take Austedo XR or Austedo with food?
📖 Read our full Deutetrabenazine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color purple / blue / brown / gray / orange / pink
ShapeRound
ImprintQ18
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 3J2P07GVB6
    Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 11628IH70O
    Polyethylene oxide is a synthetic polymer derived from ethylene. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • UNII 3IG9032SAH
    A synthetic polymer derived from ethylene that forms a thick, gel-like substance in water. It acts as a binder and thickener in medications, helping hold solid forms together and controlling how quickly the medicine releases into your body.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

21 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $501.993 $15,059.79 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $482.80 $14,484.12 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $513.57 $15,407.13 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 May 2026 Jun 2026 Aug 2026 $502.289 $498.628
▲ Up 1% over the last 5 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Austedo Xr 48 mgthis 68546-0476-56 Teva 30 tablets $501.993 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
First FDA approval
May 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 29, 2024 RLD RS ⏳ ~14.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-3055)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 12016858 — method of use (U-1995)
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-1995)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-1995)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 11311488 — method of use (U-1995)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-1995)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-1995)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-1995)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-1995)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-3055)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-3055)
US 11179386 — method of use (U-1995)
US 11179386 — method of use (U-1995)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 10959996 — method of use (U-3055)
US 11311488 — method of use (U-1995)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-3055)
US 11311488 — method of use (U-1995)
US 11311488 — method of use (U-1995)
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-3055)
US 9550780 — drug substance (U-1995)
US 9550780 — drug substance (U-1995)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11564917 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11446291 — method of use (U-1995)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-3055)
US 11357772 — method of use (U-1995)
US 11357772 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 11648244 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12599598 — method of use (U-3055)
US 12599598 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 12589075 — method of use (U-3055)
US 12589075 — method of use (U-1995)
US 8524733 — drug substance
US 11813232 — drug product
US 8524733 — drug substance
US 8524733 — drug substance
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US 11813232 — drug product
US 8524733 — drug substance
US 8524733 — drug substance
US 8524733 — drug substance
US 11813232 — drug product
US 11813232 — drug product
US 11813232 — drug product
US 11813232 — drug product
US 11813232 — drug product
US 8524733 — drug substance
US 8524733 — drug substance
US 11813232*PED — drug product
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US 11648244*PED — drug product
US 11648244*PED — drug product
US 11648244*PED — drug product
US 11446291*PED — drug product
US 11446291*PED — drug product
US 11446291*PED — drug product
US 11446291*PED — drug product
US 11446291*PED — drug product
US 11564917*PED — drug product
US 11564917*PED — drug product
US 11564917*PED — drug product
US 11564917*PED — drug product
US 11564917*PED — drug product
US 11648244*PED — drug product
US 11648244*PED — drug product
US 11648244*PED — drug product
US 11648244*PED — drug product
US 11648244*PED — drug product
US 11813232*PED — drug product
US 11813232*PED — drug product
US 11813232*PED — drug product
US 11813232*PED — drug product
US 11813232*PED — drug product
US 9550780*PED — drug product
US 9550780*PED — drug product
US 9550780*PED — drug product
US 9550780*PED — drug product
US 9550780*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 8524733*PED — drug product
US 8524733*PED — drug product
US 8524733*PED — drug product
US 8524733*PED — drug product
US 8524733*PED — drug product
US 10959996*PED — drug product
US 10959996*PED — drug product
US 10959996*PED — drug product
US 10959996*PED — drug product
US 10959996*PED — drug product
US 11357772*PED — drug product
US 11357772*PED — drug product
US 11357772*PED — drug product
US 11357772*PED — drug product
US 11357772*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 12016858*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 11179386*PED — drug product
US 10959996*PED — drug product
US 10959996*PED — drug product
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2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (240)
PatentTypeUse codeExpires
US 11446291 ↗ Method of use U-1995 Mar 7, 2036
US 11446291 ↗ Method of use U-1995 Mar 7, 2036
US 11446291 ↗ Method of use U-1995 Mar 7, 2036
US 11446291 ↗ Method of use U-1995 Mar 7, 2036
US 11446291 ↗ Method of use U-1995 Mar 7, 2036
US 11564917 ↗ Method of use U-1995 Mar 7, 2036
US 11564917 ↗ Method of use U-1995 Mar 7, 2036
US 11564917 ↗ Method of use U-1995 Mar 7, 2036
US 11564917 ↗ Method of use U-1995 Mar 7, 2036
US 11564917 ↗ Method of use U-1995 Mar 7, 2036
US 11648244 ↗ Method of use U-1995 Mar 7, 2036
US 11648244 ↗ Method of use U-1995 Mar 7, 2036
US 11648244 ↗ Method of use U-1995 Mar 7, 2036
US 11648244 ↗ Method of use U-1995 Mar 7, 2036
US 11648244 ↗ Method of use U-1995 Mar 7, 2036
US 12016858 ↗ Method of use U-1995 Mar 7, 2036
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Common questions
Is there a generic version of AUSTEDO XR 48 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for AUSTEDO XR 48 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68546-0476-56, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.7K
Units reimbursed last 4 qtrs
79.8K
Gross reimbursed last 4 qtrs
$38.51M
Avg / prescription
$14,143.69
Avg / unit
$482.80
Latest quarter Q4 2025
877Rx
Medicaid pays / ea
$482.80
gross reimbursed
vs
NADAC / ea
$501.99
acquisition cost
=
Spread
−$19.1890
-4% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
44% FFS 56% MCO
Fee-for-service · 1,204 Rx Managed care · 1,519 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 2,682 units · 34.3 per 100k residents WA Idaho: 330 units · 16.8 per 100k residents ID Montana: 390 units · 34.5 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,048 units · 18.3 per 100k residents MN Wisconsin: 2,543 units · 43.0 per 100k residents WI Michigan: 3,823 units · 38.1 per 100k residents MI New York: 6,552 units · 33.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 720 units · 22.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 542 units · 16.9 per 100k residents IA Illinois: no data reported IL Indiana: 1,870 units · 27.3 per 100k residents IN Ohio: 7,119 units · 60.4 per 100k residents OH Pennsylvania: 4,290 units · 33.1 per 100k residents PA New Jersey: 1,768 units · 19.0 per 100k residents NJ Massachusetts: no data reported MA California: 10,793 units · 27.7 per 100k residents CA Utah: no data reported UT Colorado: 3,420 units · 58.2 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 976 units · 21.6 per 100k residents KY West Virginia: no data reported WV Virginia: 1,200 units · 13.8 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 3,547 units · 47.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 2,100 units · 29.5 per 100k residents TN North Carolina: 5,921 units · 54.6 per 100k residents NC South Carolina: 420 units · 7.8 per 100k residents SC Delaware: no data reported DE Oklahoma: 2,670 units · 65.9 per 100k residents OK Louisiana: 2,310 units · 50.5 per 100k residents LA Mississippi: no data reported MS Alabama: 2,017 units · 39.5 per 100k residents AL Georgia: 2,630 units · 23.8 per 100k residents GA D.C.: no data reported DC Hawaii: 490 units · 34.1 per 100k residents HI Texas: 5,231 units · 17.1 per 100k residents TX Florida: 2,368 units · 10.5 per 100k residents FL
Units reimbursed · per 100k residents
7.865.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Oklahoma 65.9 /100k
2 Ohio 60.4 /100k
3 Colorado 58.2 /100k
4 North Carolina 54.6 /100k
5 Louisiana 50.5 /100k
6 Arizona 47.7 /100k
7 Wisconsin 43.0 /100k
8 Alabama 39.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Austedo XR — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Austedo XR. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$384.4M
Claims incl. refills
38.3K
Beneficiaries
13.9K
Spend / beneficiary
$27,748.50
Spend / claim
$10,029.22
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Deutetrabenazine — the ingredient across all brands.

Top reported reactions

Depression521
Death512
Dyskinesia468
Tremor365
Somnolence350
Suicidal Ideation343
Fatigue331

Age at onset

Child3
Adolescent7
Adult785
Elderly458

Reporter sex

7,234 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization937
Death581
Disabling63
Life-threatening25
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,448 528
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68546-0476-56 You're viewing this 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-476-56) 2024-05-29 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior.

Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].

WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease ( 5.1 ) Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of AUSTEDO XR or AUSTEDO ( 5.1 ) Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior ( 5.1 ) Inform patients, caregivers, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician ( 5.1 ) Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 ) AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression ( 4 , 5.1 )

🎯 Indications and Usage 68 words ▾

1 INDICATIONS AND USAGE AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION AUSTEDO XR AUSTEDO Recommended Starting Dosage 12 mg once daily (12 mg per day) 6 mg twice daily (12 mg per day) Titrate at weekly intervals by 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg ( 2.1 ) Administer AUSTEDO XR with or without food in once-daily doses ( 2.1 ) Administer AUSTEDO with food and administer total daily dosages of 12 mg or above in two divided doses ( 2.1 ) Swallow tablets whole; do not chew, crush, or break ( 2.1 ) If switching patients from tetrabenazine, discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day.

See full prescribing information for recommended conversion table ( 2.2 ) Maximum recommended dosage of AUSTEDO XR or AUSTEDO in poor CYP2D6 metabolizers is 36 mg per day ( 2.4 , 8.7 )

2.1Dosing Information The dose of AUSTEDO XR and AUSTEDO is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. Table 1 displays the recommended dosage and important administration instructions of AUSTEDO XR and AUSTEDO when first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor). Table 1: Recommended Dosage and Important Administration Instructions for AUSTEDO XR and AUSTEDO AUSTEDO XR extended-release tablet AUSTEDO tablet Recommended Starting Dosage 12 mg once daily (12 mg per day) 6 mg twice daily (12 mg per day) Recommended Dose Titration The dosage of AUSTEDO XR or AUSTEDO may be increased at weekly intervals in increments of 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg [see Clinical Trials ( 14.1 , 14.2 )] .

Important Administration Instructions Administer AUSTEDO XR with or without food [see Clinical Pharmacology ( 12.3 )] . Swallow AUSTEDO XR whole. Do not chew, crush, or break tablets.

Administer AUSTEDO XR once daily. Administer AUSTEDO with food [see Clinical Pharmacology ( 12.3 )] . Swallow AUSTEDO whole.

Do not chew, crush, or break tablets. Administer AUSTEDO total daily dosages of 12 mg or above in two divided doses. Switching Between AUSTEDO and AUSTEDO XR When switching between AUSTEDO tablets (twice daily) and AUSTEDO XR extended-release tablets (once daily), switch to the same total daily dosage.

2.2Switching Patients from Tetrabenazine to AUSTEDO XR or AUSTEDO Discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day. The recommended initial dosing regimen of AUSTEDO XR or AUSTEDO in patients switching from tetrabenazine to AUSTEDO XR or AUSTEDO is shown in Table 2. Table 2: Recommended Initial Dosing Regimen when Switching from Tetrabenazine to AUSTEDO XR or AUSTEDO Current tetrabenazine daily dosage Initial regimen of AUSTEDO XR extended-release tablet Initial regimen of AUSTEDO tablet 12.5 mg 6 mg once daily 6 mg once daily 25 mg 12 mg once daily 6 mg twice daily 37.5 mg 18 mg once daily 9 mg twice daily 50 mg 24 mg once daily 12 mg twice daily 62.5 mg 30 mg once daily 15 mg twice daily 75 mg 36 mg once daily 18 mg twice daily 87.5 mg 42 mg once daily 21 mg twice daily 100 mg 48 mg once daily 24 mg twice daily After patients are switched to AUSTEDO XR or AUSTEDO, the dose may be adjusted at weekly intervals [see Dosage and Administration ( 2.1 )] .

2.3Dosage Adjustment with Strong CYP2D6 Inhibitors In patients receiving strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO XR or AUSTEDO should not exceed 36 mg [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .

2.4Dosage Adjustment in Poor CYP2D6 Metabolizers In patients who are poor CYP2D6 metabolizers, the total daily dosage of AUSTEDO XR or AUSTEDO should not exceed 36 mg [see Use in Specific Populations ( 8.7 )].

2.5Discontinuation and Interruption of Treatment Treatment with AUSTEDO XR or AUSTEDO can be discontinued without tapering. Following treatment interruption…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS AUSTEDO XR extended-release tablets are available in the following strengths: The 6 mg extended-release tablets are round, grey-coated tablets, with “Q6” printed in black ink on one side. The 12 mg extended-release tablets are round, blue-coated tablets, with “Q12” printed in black ink on one side. The 18 mg extended-release tablets are round, light grey-coated tablets, with “Q18” printed in black ink on one side.

The 24 mg extended-release tablets are round, purple-coated tablets, with “Q24” printed in black ink on one side. The 30 mg extended-release tablets are round, light orange-coated tablets, with “Q30” printed in black ink on one side. The 36 mg extended-release tablets are round, light purple-coated tablets, with “Q36” printed in black ink on one side.

The 42 mg extended-release tablets are round, orange-coated tablets, with “Q42” printed in black ink on one side. The 48 mg extended-release tablets are round, pink-coated tablets, with “Q48” printed in black ink on one side. AUSTEDO tablets are available in the following strengths: The 6 mg tablets are round, purple-coated tablets, with “SD” over “6” printed in black ink on one side.

The 9 mg tablets are round, blue-coated tablets, with “SD” over “9” printed in black ink on one side. The 12 mg tablets are round, beige-coated tablets, with “SD” over “12” printed in black ink on one side. Extended-release tablets: 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, and 48 mg ( 3 ) Tablets: 6 mg, 9 mg, and 12 mg ( 3 )

⛔ Contraindications 157 words ▾

4 CONTRAINDICATIONS AUSTEDO XR and AUSTEDO are contraindicated in patients: With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression [see Warnings and Precautions ( 5.1 )] . With hepatic impairment [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Taking reserpine.

At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO [see Drug Interactions ( 7.2 )] . Taking monoamine oxidase inhibitors (MAOIs). AUSTEDO XR and AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see Drug Interactions ( 7.3 )] .

Taking tetrabenazine or valbenazine [see Drug Interactions ( 7.6 )] . Suicidal, or untreated/inadequately treated depression in patients with Huntington’s disease ( 4 , 5.1 ) Hepatic impairment ( 4 , 8.6 , 12.3 ) Taking reserpine, MAOIs, tetrabenazine, or valbenazine ( 4 , 7.2 , 7.3 , 7.6 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS QT Prolongation: Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval ( 5.3 ) Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs ( 5.4 ) Akathisia, agitation, restlessness, and parkinsonism: Reduce dose or discontinue if this occurs ( 5.5 , 5.6 ) Sedation/somnolence: May impair the patient’s ability to drive or operate complex machinery ( 5.7 )

5.1Depression and Suicidality in Patients with Huntington’s Disease Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors (suicidality). AUSTEDO XR and AUSTEDO may increase the risk for suicidality in patients with Huntington’s disease. In a 12-week, double-blind, placebo-controlled trial, suicidal ideation was reported by 2% of patients treated with AUSTEDO, compared to no patients on placebo; no suicide attempts and no completed suicides were reported.

Depression was reported by 4% of patients treated with AUSTEDO. When considering the use of AUSTEDO XR or AUSTEDO, the risk of suicidality should be balanced against the need for treatment of chorea. All patients treated with AUSTEDO XR or AUSTEDO should be observed for new or worsening depression or suicidality.

If depression or suicidality does not resolve, consider discontinuing treatment with AUSTEDO XR or AUSTEDO. Patients, their caregivers, and families should be informed of the risks of depression, worsening depression, and suicidality associated with AUSTEDO XR and AUSTEDO, and should be instructed to report behaviors of concern promptly to the treating physician. Patients with Huntington’s disease who express suicidal ideation should be evaluated immediately.

5.2Clinical Worsening and Adverse Events in Patients with Huntington’s Disease Huntington’s disease is a progressive disorder characterized by changes in mood, cognition, chorea, rigidity, and functional capacity over time. VMAT2 inhibitors, including AUSTEDO XR and AUSTEDO, may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects, including sedation/somnolence, depression and suicidality, parkinsonism, akathisia, restlessness, and cognitive decline.

It may be difficult to distinguish between adverse reactions and progression of the underlying disease; decreasing the dose or stopping the drug may help the clinician to distinguish between the two possibilities. In some patients, the underlying chorea itself may improve over time, decreasing the need for AUSTEDO XR or AUSTEDO.

5.3QTc Prolongation AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range [see Clinical Pharmacology (12.2)] . AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval.

5.4Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission. While NMS has not been observed in patients receiving AUSTEDO XR or AUSTEDO, it has been observed in patients receiving tetrabenazine (a closely related VMAT2 inhibitor). Clinicians should be alerted to the signs and symptoms associated with NMS.

Clinical manifestations of NMS are hyperpyrexia, muscle rigidit…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Depression and Suicidality in Patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )] QTc Prolongation [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.4 )] Akathisia, Agitation, and Restlessness [see Warnings and Precautions ( 5.5 )] Parkinsonism [see Warnings and Precautions ( 5.6 )] Sedation and Somnolence [see Warnings and Precautions ( 5.7 )] Hyperprolactinemia [see Warnings and Precautions ( 5.8 )] Binding to Melanin-Containing Tissues [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>8% of AUSTEDO-treated patients with Huntington’s disease and greater than placebo): somnolence, diarrhea, dry mouth, and fatigue ( 6.1 ) Most common adverse reactions (that occurred in 4% of AUSTEDO-treated patients with tardive dyskinesia and greater than placebo): nasopharyngitis and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The studies described below were conducted with AUSTEDO tablets; adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. Patients with Huntington’s Disease Study 1 [see Clinical Studies ( 14.1 )] was a randomized, 12-week, placebo-controlled study in patients with chorea associated with Huntington’s disease.

A total of 45 patients received AUSTEDO, and 45 patients received placebo. Patients ranged in age between 23 and 74 years (mean 54 years); 56% were male, and 92% were Caucasian. The most common adverse reactions occurring in greater than 8% of AUSTEDO-treated patients were somnolence, diarrhea, dry mouth, and fatigue.

Adverse reactions occurring in 4% or more of patients treated with AUSTEDO, and with a greater incidence than in patients on placebo, are summarized in Table 3. Table 3: Adverse Reactions in Patients with Huntington's Disease (Study 1) Experienced by at Least 4% of Patients on AUSTEDO and with a Greater Incidence than on Placebo Adverse Reaction AUSTEDO (N = 45) % Placebo (N = 45) % Somnolence 11 4 Diarrhea 9 0 Dry mouth 9 7 Fatigue 9 4 Urinary tract infection 7 2 Insomnia 7 4 Anxiety 4 2 Constipation 4 2 Contusion 4 2 One or more adverse reactions resulted in a reduction of the dose of study medication in 7% of patients in Study 1.

The most common adverse reaction resulting in dose reduction in patients receiving AUSTEDO was dizziness (4%). Agitation led to discontinuation in 2% of patients treated with AUSTEDO in Study 1. Patients with Tardive Dyskinesia The data described below reflect 410 tardive dyskinesia patients participating in clinical trials.

AUSTEDO was studied primarily in two 12-week, placebo-controlled trials (fixed dose, dose escalation) [see Clinical Studies ( 14.2 )] . The population was 18 to 80 years of age, and had tardive dyskinesia and had concurrent diagnoses of mood disorder (33%) or schizophrenia/schizoaffective disorder (63%). In these studies, AUSTEDO was administered in doses ranging from 12-48 mg per day.

All patients continued on previous stable regimens of antipsychotics; 71% and 14% respective atypical and typical antipsychotic medications at study entry. The most common adverse reactions occurring in greater than 3% of AUSTEDO-treated patients and greater than placebo were nasopharyngitis and insomnia. The adverse reactions occurring in >2% or more patients treated with AUSTEDO (12-48 mg per day) and greater than in placebo patients in two double-blind, placebo-controlled studies in patients with…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO XR or AUSTEDO is 36 mg per day ( 2.3 , 7.1 ) Alcohol or other sedating drugs: May have additive sedation and somnolence ( 7.5 )

7.1Strong CYP2D6 Inhibitors A reduction in AUSTEDO XR or AUSTEDO dose may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose of AUSTEDO XR or AUSTEDO. Concomitant use of strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. The daily dose of AUSTEDO XR or AUSTEDO should not exceed 36 mg per day in patients taking strong CYP2D6 inhibitors [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )].

7.2Reserpine Reserpine binds irreversibly to VMAT2 and the duration of its effect is several days. Prescribers should wait for chorea or dyskinesia to reemerge before administering AUSTEDO XR or AUSTEDO to help reduce the risk of overdosage and major depletion of serotonin and norepinephrine in the central nervous system. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO.

AUSTEDO XR and AUSTEDO should not be used concomitantly with reserpine [see Contraindications ( 4 )] .

7.3Monoamine Oxidase Inhibitors (MAOIs) AUSTEDO XR and AUSTEDO are contraindicated in patients taking MAOIs. AUSTEDO XR and AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see Contraindications ( 4 )] .

7.4Neuroleptic Drugs The risk of parkinsonism, NMS, and akathisia may be increased by concomitant use of AUSTEDO XR or AUSTEDO with dopamine antagonists or antipsychotics.

7.5Alcohol or Other Sedating Drugs Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence [see Warnings and Precautions ( 5.7 )].

7.6Concomitant Tetrabenazine or Valbenazine AUSTEDO XR and AUSTEDO are contraindicated in patients currently taking tetrabenazine or valbenazine. AUSTEDO XR or AUSTEDO may be initiated the day following discontinuation of tetrabenazine [see Dosage and Administration ( 2.2 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AUSTEDO XR or AUSTEDO in pregnant women. Administration of deutetrabenazine to rats during organogenesis produced no clear adverse effect on embryofetal development. However, administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality [see Data].

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of deutetrabenazine (5, 10, or 30 mg/kg/day) or tetrabenazine (30 mg/kg/day) to pregnant rats during organogenesis had no clear effect on embryofetal development.

The highest dose tested was 6 times the maximum recommended human dose of 48 mg/day, on a body surface area (mg/m 2 ) basis. The effects of deutetrabenazine when administered during organogenesis to rabbits or during pregnancy and lactation to rats have not been assessed. Tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day.

When tetrabenazine was administered to female rats (doses of 5, 15, and 30 mg/kg/day) from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day, and delayed pup maturation was observed at all doses.

8.2Lactation Risk Summary There are no data on the presence of deutetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AUSTEDO XR or AUSTEDO and any potential adverse effects on the breastfed infant from AUSTEDO XR or AUSTEDO or from the underlying maternal condition.

8.4Pediatric Use Chorea associated with Huntington’s Disease and Tardive Dyskinesia The safety and effectiveness of AUSTEDO XR and AUSTEDO have not been established in pediatric patients for the treatment of chorea associated with Huntington’s disease or for the treatment of tardive dyskinesia. Tourette Syndrome The safety and effectiveness of AUSTEDO XR and AUSTEDO have not been established in pediatric patients for the treatment of Tourette syndrome. Efficacy was not demonstrated in two randomized, double-blind, placebo-controlled studies in pediatric patients aged 6 to 16 years with Tourette syndrome.

One study evaluated fixed doses of deutetrabenazine over 8 weeks (NCT03571256); the other evaluated flexible doses of deutetrabenazine over 12 weeks (NCT03452943). The studies included a total of 274 pediatric patients who received at least one dose of deutetrabenazine or placebo. The primary efficacy endpoint in both studies was the change from baseline to end-of-treatment on the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS).

The estimated treatment effect of deutetrabenazine on the YGTSS-TTS was not statistically significantly different from placebo in either study. The placebo subtracted least squares means difference in YGTSS-TTS from baseline to end-of-treatment was -0.7 (95% CI: -4.1, 2.8) in the flexible dose study and -0.8 (95% CI: -3.9, 2.3) for the primary analysis in the fixed dose study. The following adverse reactions were reported in frequencies of at least 5% of pediatric patients treated with AUSTEDO and with a greater incidence than in pediatric patients receiving placebo (AUSTEDO vs placebo): headache (includes: migraine, migraine with aura, and headache; 13% vs 9%), somnolence (includes: sedation, hypersomnia, and somnolence…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AUSTEDO XR or AUSTEDO in pregnant women. Administration of deutetrabenazine to rats during organogenesis produced no clear adverse effect on embryofetal development. However, administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality [see Data].

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of deutetrabenazine (5, 10, or 30 mg/kg/day) or tetrabenazine (30 mg/kg/day) to pregnant rats during organogenesis had no clear effect on embryofetal development.

The highest dose tested was 6 times the maximum recommended human dose of 48 mg/day, on a body surface area (mg/m 2 ) basis. The effects of deutetrabenazine when administered during organogenesis to rabbits or during pregnancy and lactation to rats have not been assessed. Tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day.

When tetrabenazine was administered to female rats (doses of 5, 15, and 30 mg/kg/day) from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day, and delayed pup maturation was observed at all doses.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Chorea associated with Huntington’s Disease and Tardive Dyskinesia The safety and effectiveness of AUSTEDO XR and AUSTEDO have not been established in pediatric patients for the treatment of chorea associated with Huntington’s disease or for the treatment of tardive dyskinesia. Tourette Syndrome The safety and effectiveness of AUSTEDO XR and AUSTEDO have not been established in pediatric patients for the treatment of Tourette syndrome. Efficacy was not demonstrated in two randomized, double-blind, placebo-controlled studies in pediatric patients aged 6 to 16 years with Tourette syndrome.

One study evaluated fixed doses of deutetrabenazine over 8 weeks (NCT03571256); the other evaluated flexible doses of deutetrabenazine over 12 weeks (NCT03452943). The studies included a total of 274 pediatric patients who received at least one dose of deutetrabenazine or placebo. The primary efficacy endpoint in both studies was the change from baseline to end-of-treatment on the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS).

The estimated treatment effect of deutetrabenazine on the YGTSS-TTS was not statistically significantly different from placebo in either study. The placebo subtracted least squares means difference in YGTSS-TTS from baseline to end-of-treatment was -0.7 (95% CI: -4.1, 2.8) in the flexible dose study and -0.8 (95% CI: -3.9, 2.3) for the primary analysis in the fixed dose study. The following adverse reactions were reported in frequencies of at least 5% of pediatric patients treated with AUSTEDO and with a greater incidence than in pediatric patients receiving placebo (AUSTEDO vs placebo): headache (includes: migraine, migraine with aura, and headache; 13% vs 9%), somnolence (includes: sedation, hypersomnia, and somnolence; 11% vs 2%), fatigue (8% vs 3%), increased appetite (5% vs <1%), and increased weight (5% vs <1%).

Juvenile Animal Toxicity Data Deutetrabenazine orally administered to juvenile rats from postnatal days 21 through 70 (at 2.5, 5, or 10 mg/kg/day) resulted in an increased incidence of tremor, hyperactivity, and adverse increases in motor activity at ≥5 mg/kg/day, and reduced body weight and food consumption at 10 mg/kg/day. There was no reproductive or early embryonic toxicity up to the highest dose. All drug-related findings were reversible after a drug-free period.

The no observed adverse effect level (NOAEL) in juvenile rats was 2.5 mg/kg/day. These drug-related findings were similar to those observed in adult rats; however, the juvenile rats were more sensitive.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Clinical studies of AUSTEDO XR and AUSTEDO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of hepatic, renal, and cardiac dysfunction, and of concomitant disease or other drug therapy.

🆘 Overdosage 127 words ▾

10 OVERDOSAGE Overdoses ranging from 100 mg to 1 g have been reported in the literature with tetrabenazine, a closely related VMAT2 inhibitor. The following adverse reactions occurred with overdosing: acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor. Treatment should consist of those general measures employed in the management of overdosage with any central nervous system-active drug.

General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered.

The physician should consider contacting a poison control center on the treatment of any overdose. Telephone numbers for certified poison control centers are listed on the American Association of Poison Control Centers website www.aapcc.org.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which deutetrabenazine exerts its effects in the treatment of tardive dyskinesia and chorea in patients with Huntington’s disease is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.

12.2Pharmacodynamics Cardiac Electrophysiology At the maximum recommended dose, AUSTEDO XR and AUSTEDO do not prolong the QT interval to any clinically relevant extent. An exposure-response analysis on QTc prolongation from a study in extensive or intermediate (EM) and poor CYP2D6 metabolizers (PM) showed that a clinically-relevant effect can be excluded at exposures following single doses of 24 and 48 mg of AUSTEDO. Melanin Binding Deutetrabenazine or its metabolites bind to melanin-containing tissues (i.e., eye, skin, fur) in pigmented rats.

After a single oral dose of radiolabeled deutetrabenazine, radioactivity was still detected in eye and fur at 35 days following dosing [see Warnings and Precautions ( 5.9 )].

12.3Pharmacokinetics After oral dosing, plasma concentrations of deutetrabenazine are low compared to that of the active deuterated metabolites because of the extensive hepatic metabolism of deutetrabenazine. AUSTEDO XR Systemic exposure (i.e., peak plasma concentrations [C max ] and the area under the plasma concentration-time curve [AUC]) for deutetrabenazine and the active, deuterated dihydro metabolites (HTBZ), α-HTBZ and β-HTBZ, increased proportionally to dose following single doses of AUSTEDO XR over the recommended clinical dosage range (6 mg to 48 mg).

AUSTEDO Systemic exposure (C max and AUC) for the active metabolites increased proportionally to dose following single or multiple doses of deutetrabenazine (6 mg to 24 mg and 7.5 mg twice daily to 22.5 mg twice daily). Absorption Following oral administration of deutetrabenazine, the extent of absorption is at least 80%. AUSTEDO XR Peak plasma concentrations (C max ) of deutetrabenazine, deuterated α-HTBZ, and β-HTBZ are reached within approximately 3 hours, followed by sustained plateaus for several hours allowing for a 24-hour dosing interval.

AUSTEDO Peak plasma concentrations (C max ) of deutetrabenazine, deuterated α-HTBZ and β-HTBZ are reached within 3 to 4 hours after dosing. Effect of Food AUSTEDO XR The effects of food on the bioavailability of AUSTEDO XR were studied in subjects administered a single dose with and without food. Food had no effect on C max or AUC of deutetrabenazine, α-HTBZ or β-HTBZ [see Dosage and Administration ( 2.1 )] .

AUSTEDO The effects of food on the bioavailability of AUSTEDO were studied in subjects administered a single dose with and without food. Food had no effect on AUC of α-HTBZ or β-HTBZ, although C max was increased by approximately 50% in the presence of food [see Dosage and Administration ( 2.1 )] . Distribution The median volume of distribution (Vc/F) of the α-HTBZ, and the β-HTBZ metabolites of deutetrabenazine are approximately 500 L and 730 L, respectively.

Results of PET-scan studies in humans show that following intravenous injection of 11 C-labeled tetrabenazine or α-HTBZ, radioactivity is rapidly distributed to the brain, with the highest binding in the striatum and lowest binding in the cortex. The protein binding of deutetrabenazine and deuterated α-HTBZ and β-HTBZ in human plasma at the concentration of 0.1 µM is 82%, 57%, and 49% respectively, with no preferential binding of drug-related total radioactivity to the cellular components of human blood. Elimination AUSTEDO XR and AUSTEDO are primarily renally eliminated in the form of metabolites.

The half-life of the active deuterated α-HTBZ, β-H…

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action The precise mechanism by which deutetrabenazine exerts its effects in the treatment of tardive dyskinesia and chorea in patients with Huntington’s disease is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied AUSTEDO XR extended-release tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg Round, grey-coated tablets, with “Q6” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-470-56 12 mg Round, blue-coated tablets, with “Q12” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-471-56 18 mg Round, light grey-coated tablets, with “Q18” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-479-56 24 mg Round, purple-coated tablets, with “Q24” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-472-56 30 mg Round, light orange-coated tablets, with “Q30” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-473-56 36 mg Round, light purple-coated tablets, with “Q36” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-474-56 42 mg Round, orange-coated tablets, with “Q42” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-475-56 48 mg Round, pink-coated tablets, with “Q48” printed in black ink on one side Bottle with child-resistant cap / 30 count 68546-476-56 AUSTEDO XR Patient Titration Kits are supplied in the following configuration: Strength Description Package Configuration NDC Code 4-Week Patient Titration Kit 12 mg Round, blue-coated tablets, with “Q12” printed in black ink on one side Titration Kit / 28 count Each Titration Kit contains 1 child-resistant blister pack, containing one foil card with extended-release tablets in the following configuration: Seven 12 mg tablets taken during Week 1; seven 18 mg tablets taken during Week 2; seven 24 mg tablets taken during Week 3; and seven 30 mg tablets taken during Week 4.

68546-477-29 18 mg Round, light grey-coated tablets, with “Q18” printed in black ink on one side 24 mg Round, purple-coated tablets, with “Q24” printed in black ink on one side 30 mg Round, light orange-coated tablets, with “Q30” printed in black ink on one side AUSTEDO tablets are supplied in the following configurations: Strength Description Package Configuration NDC Code 6 mg Round, purple-coated tablets, with “SD” over “6” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-170-60 9 mg Round, blue-coated tablets, with “SD” over “9” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-171-60 12 mg Round, beige-coated tablets, with “SD” over “12” printed in black ink on one side Bottle with child-resistant cap / 60 count 68546-172-60

16.2Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from light and moisture. Dispense in original containers or in tight containers as defined in USP.

📋 Description ~2 min read ▾

11 DESCRIPTION AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: ( RR, SS )-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d 3 )-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.

The molecular formula for deutetrabenazine is C 19 H 21 D 6 NO 3 . Deutetrabenazine is a racemic mixture containing the following structures: Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. AUSTEDO XR AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake.

The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.

AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool.

AUSTEDO AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake. chemical-structure.jpg

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Administration Instructions Instruct patients to swallow AUSTEDO XR or AUSTEDO whole and not to chew, crush, or break AUSTEDO XR or AUSTEDO [see Dosage and Administration (2.1)]. AUSTEDO XR Advise patients to take AUSTEDO XR with or without food in once-daily doses.

Inform patients not to be concerned if they occasionally notice something that looks like a tablet shell in their stool [see Description ( 11 )] . AUSTEDO Advise patients to take AUSTEDO with food. Advise patients to take daily dosages of 12 mg or higher in two divided doses (twice daily).

Risk of Depression and Suicide in Patients with Huntington’s Disease Advise patients, their caregivers, and families that AUSTEDO XR and AUSTEDO may increase the risk of depression, worsening depression, and suicidality, and to immediately report any symptoms to a healthcare provider [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . Prolongation of the QTc Interval Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations [see Warnings and Precautions ( 5.3 )] .

Advise patients to inform physicians that they are taking AUSTEDO XR or AUSTEDO before any new drug is taken. Parkinsonism Inform patients that AUSTEDO XR and AUSTEDO may cause Parkinson-like symptoms, which could be severe. Advise patients to consult their healthcare provider if they experience slight shaking, body stiffness, trouble moving, trouble keeping their balance, or falls [see Warnings and Precautions ( 5.6 )].

Risk of Sedation and Somnolence Advise patients that AUSTEDO XR and AUSTEDO may cause sedation and somnolence and may impair the ability to perform tasks that require complex motor and mental skills. Until they learn how they respond to a stable dose of AUSTEDO XR or AUSTEDO, patients should be careful doing activities that require them to be alert, such as driving a car or operating machinery [see Warnings and Precautions ( 5.7 )] . Interaction with Alcohol or Other Sedating Drugs Advise patients that alcohol or other drugs that cause sleepiness will worsen somnolence [see Drug Interactions ( 7.5 )] .

Concomitant Medications Advise patients to notify their physician of all medications they are taking and to consult with their healthcare provider before starting any new medications because of a potential for interactions [see Contraindications ( 4 ) and Drug Interactions ( 7.1 , 7.4 )]. Manufactured for: Teva Neuroscience, Inc. Parsippany, NJ 07054 © 2025 Teva Neuroscience, Inc.

AUS-013 AUSTEDO XR U.S. Patent Nos: 8,524,733; 9,550,780; 10,959,996; 11,179,386; 11,357,772; 11,311,488; 11,564,917; 11,446,291; 11,648,244; 11,813,232; 12,016,858 AUSTEDO U.S. Patent Nos: 8,524,733; 9,233,959; 9,296,739; 9,550,780; 9,814,708; 10,959,996; 11,179,386; 11,357,772; 11,564,917; 11,446,291; 11,648,244; 11,666,566; 11,813,232; 12,016,858

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE MEDICATION GUIDE AUSTEDO XR ® ( aw-STED-oh XR ) (deutetrabenazine) extended-release tablets, for oral use AUSTEDO ® ( aw-STED-oh ) (deutetrabenazine) tablets, for oral use What is the most important information I should know about AUSTEDO XR and AUSTEDO? AUSTEDO XR and AUSTEDO can cause serious side effects in people with Huntington’s disease, including: depression suicidal thoughts suicidal actions Do not start taking AUSTEDO XR or AUSTEDO if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when AUSTEDO XR or AUSTEDO is started and when the dose is changed. Call your healthcare provider right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you: feel sad or have crying spells lose interest in seeing your friends or doing things you used to enjoy sleep a lot more or a lot less than usual feel unimportant feel guilty feel hopeless or helpless feel more irritable, angry, or aggressive than usual feel more or less hungry than usual or notice a big change in your body weight have trouble paying attention feel tired or sleepy all the time have thoughts about hurting yourself or ending your life What are AUSTEDO XR and AUSTEDO?

AUSTEDO XR and AUSTEDO are prescription medicines that are used to treat: the involuntary movements (chorea) of Huntington’s disease. AUSTEDO XR and AUSTEDO do not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions. movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). It is not known if AUSTEDO XR and AUSTEDO are safe and effective in children.

Who should not take AUSTEDO XR or AUSTEDO? Do not take AUSTEDO XR or AUSTEDO if you: have Huntington’s disease and are depressed or have thoughts of suicide. See “ What is the most important information I should know about AUSTEDO XR and AUSTEDO? ” have liver problems. are taking reserpine.

Do not take medicines that contain reserpine with AUSTEDO XR or AUSTEDO. If your healthcare provider plans to switch you from taking reserpine to AUSTEDO XR or AUSTEDO, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDO XR or AUSTEDO. are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking AUSTEDO XR or AUSTEDO.

Do not start AUSTEDO XR or AUSTEDO if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure. are taking tetrabenazine. If your healthcare provider plans to switch you from tetrabenazine to AUSTEDO XR or AUSTEDO, take your first dose of AUSTEDO XR or AUSTEDO on the day after your last dose of tetrabenazine. are taking valbenazine.

Before taking AUSTEDO XR or AUSTEDO, tell your healthcare provider about all of your medical conditions, including if you: have emotional or mental problems (for example, depression, nervousness, anxiety, anger, agitation, psychosis, previous suicidal thoughts or suicide attempts). have liver disease. have an irregular heart rhythm or heartbeat (QT prolongation, cardiac arrhythmia) or a heart problem called congenital long QT syndrome. have low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia). have breast cancer or a history of breast cancer. are pregnant or plan to become pregnant.

It is not known if AUSTEDO XR or AUSTEDO can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if AUSTEDO XR or AUSTEDO passes into breast milk. Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supple…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.