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Bylvay odevixibat 200 ug Capsule, Coated Pellets, 30-count — NDC 15054-3301-01 package photo

Bylvay odevixibat 200 ug Capsule, Coated Pellets, 30-count

by Ipsen Biopharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE
NDC 15054-3301-01
🏷️ FDA NDC (as labeled) 15054-3301-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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) 15054-3301-1
Product NDC 15054-3301
11-digit billing NDC 15054330101
NCPDP billing unit EA — each (per item)
RxCUI 2563983, 2563989, 2563991, 2563993, 2563997, 2564001, 2564003, 2564005
UNII 2W150K0UUC
Application # NDA215498
SPL Set ID 0935cd31-3251-4a0a-ac23-25ca4be12be9
Established class (EPC) Ileal Bile Acid Transporter Inhibitor
Mechanism of action Ileal Bile Acid Transporter Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-10
Route ORAL
Dosage form CAPSULE, COATED PELLETS
Substance ODEVIXIBAT
GPI-14 52350060006810
GCN Seq No 082527
GCN 49976
HICL code 047501
Ingredient (HICL) Odevixibat
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7F
Therapeutic class — specific (HIC3) Ileal Bile Acid Transporter (Ibat) Inhibitor
AHFS code 56:14.00.00
AHFS class Cholelitholytic Agents
FDB label name BYLVAY 200 MCG PELLET
FDB brand name Bylvay
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 15054-3301-1 — a 5-4-1 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 package segment → 15054-3301-01. 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 Ileal Bile Acid Transporter Inhibitor class.

Pharmacologic class Ileal Bile Acid Transporter Inhibitor
Drug family (ATC) Other drugs for bile therapy
How it works Ileal Bile Acid Transporter Inhibitors
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

LabelerIpsen Biopharmaceuticals, Inc.
Application holderIPSEN BIOPHARMACEUTICALS INC
FDA applicationNDA215498 (NDA)
Labeler code15054
First marketedJan 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 BYLVAY 200 MCG PELLET Ingredient Odevixibat
📖 What it is MedlinePlus · NLM

Odevixibat is used to treat itching caused by familial intrahepatic cholestasis (PFIC; a liver disease in which the flow of bile from the liver is blocked) or Alagille syndrome (ALCS; an inherited condition in which bile builds up in the liver and causes liver damage). Odevixibat is in a class of medications called ileal bile acid transporter (IBAT) inhibitors. It works by decreasing the level of bile acids from the small intestine.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Bylvay works in the intestine to block the recycling of bile acids — substances produced by the liver — back into the bloodstream. In conditions like PFIC and Alagille syndrome, bi...
  • What exactly does Bylvay do, and why does my child need it?
  • Give Bylvay once every morning with the first meal of the day. Capsules should be swallowed whole — do not crush or chew them. The dose is based on your child's weight, so always f...
  • How and when should we give Bylvay each day?
📖 Read our full Odevixibat 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 White / Orange
ShapeCapsule
ImprintA1200
Size16 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.

2 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $264.32 $7,929.48 / 30 capsules
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
Bylvay 200 ugthis 15054-3301-01 Ipsen 30 capsules — — FDA listed —
Bylvay 200 ug 74528-0020-01 Albireo 30 capsules — — FDA listed —
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

🏛️
2021
First FDA approval
Jul 2021
📍
2026
Currently FDA-listed
5 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 Nov 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 20, 2021 RLD RS ⏳ ~15.2 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 12545705 — method of use (U-3186)
US 12545705 — method of use (U-3186)
US 12545705 — method of use (U-3186)
US 12545705 — method of use (U-3186)
US 12545705 — method of use (U-3648)
US 12545705 — method of use (U-3648)
US 12545705 — method of use (U-3648)
US 12545705 — method of use (U-3648)
US 12508234 — method of use (U-3186)
US 12508234 — method of use (U-3648)
US 12508234 — method of use (U-3648)
US 12508234 — method of use (U-3648)
US 12508234 — method of use (U-3648)
US 12508234 — method of use (U-3186)
US 12508234 — method of use (U-3186)
US 12508234 — method of use (U-3186)
US 10487111 — method of use (U-3186)
US 10981952 — method of use (U-3187)
US 10981952 — method of use (U-3186)
US 10981952 — method of use (U-3186)
US 10981952 — method of use (U-3187)
US 10487111 — method of use (U-3186)
US 10981952 — method of use (U-3186)
US 10981952 — method of use (U-3187)
US 10487111 — method of use (U-3186)
US 10487111 — method of use (U-3186)
US 10981952 — method of use (U-3187)
US 10981952 — method of use (U-3186)
US 9694018 — method of use (U-3186)
US 10011633 — method of use (U-3186)
US 10093697 — method of use (U-3186)
US 10093697 — method of use (U-3186)
US 10011633 — method of use (U-3186)
US 9694018 — method of use (U-3186)
US 10011633 — method of use (U-3186)
US 10093697 — method of use (U-3186)
US 9694018 — method of use (U-3186)
US 10011633 — method of use (U-3186)
US 10093697 — method of use (U-3186)
US 9694018 — method of use (U-3186)
US 12447156 — method of use (U-3186)
US 12447156 — method of use (U-3186)
US 12447156 — method of use (U-3186)
US 12447156 — method of use (U-3186)
US 11583539 — method of use (U-3186)
US 11583539 — method of use (U-3186)
US 11583539 — method of use (U-3186)
US 11583539 — method of use (U-3186)
US 10093697 — method of use (U-3648)
US 10093697 — method of use (U-3648)
US 10093697 — method of use (U-3648)
US 10093697 — method of use (U-3648)
US 10011633 — method of use (U-3648)
US 10011633 — method of use (U-3648)
US 10011633 — method of use (U-3648)
US 10011633 — method of use (U-3648)
US 9694018 — method of use (U-3648)
US 9694018 — method of use (U-3648)
US 9694018 — method of use (U-3648)
US 9694018 — method of use (U-3648)
US 11732006 — method of use (U-3648)
US 11732006 — method of use (U-3648)
US 11732006 — method of use (U-3648)
US 11732006 — method of use (U-3648)
US 11732006 — method of use (U-3186)
US 11732006 — method of use (U-3186)
US 11732006 — method of use (U-3186)
US 11732006 — method of use (U-3186)
US 12187812 — method of use (U-3186)
US 12187812 — method of use (U-3186)
US 12187812 — method of use (U-3186)
US 12187812 — method of use (U-3186)
US 12187812 — method of use (U-3648)
US 12187812 — method of use (U-3648)
US 12187812 — method of use (U-3648)
US 12187812 — method of use (U-3648)
US 11365182 — method of use (U-3648)
US 11365182 — method of use (U-3648)
US 11365182 — method of use (U-3648)
US 11365182 — method of use (U-3648)
US 10981952 — method of use (U-3648)
US 10981952 — method of use (U-3649)
US 10981952 — method of use (U-3649)
US 10981952 — method of use (U-3648)
US 10981952 — method of use (U-3648)
US 10981952 — method of use (U-3649)
US 10981952 — method of use (U-3648)
US 10981952 — method of use (U-3649)
US 10487111 — method of use (U-3648)
US 10487111 — method of use (U-3648)
US 10487111 — method of use (U-3648)
US 10487111 — method of use (U-3648)
US 11365182 — method of use (U-3186)
US 11365182 — method of use (U-3186)
US 11365182 — method of use (U-3186)
US 11365182 — method of use (U-3186)
US 11801226 — drug product
US 11801226 — drug product
US 11801226 — drug product
US 11802115 — drug product
US 12091394 — drug substance
US 11802115 — drug product
US 12091394 — drug substance
US 12091394 — drug substance
US 11802115 — drug product
US 10975046 — drug substance
US 10975046 — drug substance
US 10975046 — drug substance
US 12091394 — drug substance
US 10975046 — drug substance
US 11801226 — drug product
US 11802115 — drug product
Exclusivity I-918
Exclusivity NCE
Exclusivity ODE-363
Exclusivity ODE-436
Exclusivity I-918
Exclusivity NCE
Exclusivity ODE-363
Exclusivity ODE-436
Exclusivity I-918
Exclusivity NCE
Exclusivity ODE-363
Exclusivity ODE-436
Exclusivity I-918
Exclusivity NCE
Exclusivity ODE-363
Exclusivity ODE-436
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (112)
PatentTypeUse codeExpires
US 12545705 ↗ Method of use U-3186 Nov 8, 2031
US 12545705 ↗ Method of use U-3186 Nov 8, 2031
US 12545705 ↗ Method of use U-3186 Nov 8, 2031
US 12545705 ↗ Method of use U-3186 Nov 8, 2031
US 12545705 ↗ Method of use U-3648 Nov 8, 2031
US 12545705 ↗ Method of use U-3648 Nov 8, 2031
US 12545705 ↗ Method of use U-3648 Nov 8, 2031
US 12545705 ↗ Method of use U-3648 Nov 8, 2031
US 12508234 ↗ Method of use U-3186 Jun 20, 2039
US 12508234 ↗ Method of use U-3648 Jun 20, 2039
US 12508234 ↗ Method of use U-3648 Jun 20, 2039
US 12508234 ↗ Method of use U-3648 Jun 20, 2039
US 12508234 ↗ Method of use U-3648 Jun 20, 2039
US 12508234 ↗ Method of use U-3186 Jun 20, 2039
US 12508234 ↗ Method of use U-3186 Jun 20, 2039
US 12508234 ↗ Method of use U-3186 Jun 20, 2039
US 10487111 ↗ Method of use U-3186 Nov 8, 2031
US 10981952 ↗ Method of use U-3187 Nov 8, 2031
US 10981952 ↗ Method of use U-3186 Nov 8, 2031
US 10981952 ↗ Method of use U-3186 Nov 8, 2031
US 10981952 ↗ Method of use U-3187 Nov 8, 2031
US 10487111 ↗ Method of use U-3186 Nov 8, 2031
US 10981952 ↗ Method of use U-3186 Nov 8, 2031
US 10981952 ↗ Method of use U-3187 Nov 8, 2031
US 10487111 ↗ Method of use U-3186 Nov 8, 2031
US 10487111 ↗ Method of use U-3186 Nov 8, 2031
US 10981952 ↗ Method of use U-3187 Nov 8, 2031
US 10981952 ↗ Method of use U-3186 Nov 8, 2031
US 9694018 ↗ Method of use U-3186 Mar 18, 2034
US 10011633 ↗ Method of use U-3186 Nov 8, 2031
US 10093697 ↗ Method of use U-3186 Nov 8, 2031
US 10093697 ↗ Method of use U-3186 Nov 8, 2031
US 10011633 ↗ Method of use U-3186 Nov 8, 2031
US 9694018 ↗ Method of use U-3186 Mar 18, 2034
US 10011633 ↗ Method of use U-3186 Nov 8, 2031
US 10093697 ↗ Method of use U-3186 Nov 8, 2031
US 9694018 ↗ Method of use U-3186 Mar 18, 2034
US 10011633 ↗ Method of use U-3186 Nov 8, 2031
US 10093697 ↗ Method of use U-3186 Nov 8, 2031
US 9694018 ↗ Method of use U-3186 Mar 18, 2034
US 12447156 ↗ Method of use U-3186 Nov 12, 2041
US 12447156 ↗ Method of use U-3186 Nov 12, 2041
US 12447156 ↗ Method of use U-3186 Nov 12, 2041
US 12447156 ↗ Method of use U-3186 Nov 12, 2041
US 11583539 ↗ Method of use U-3186 Nov 12, 2041
US 11583539 ↗ Method of use U-3186 Nov 12, 2041
US 11583539 ↗ Method of use U-3186 Nov 12, 2041
US 11583539 ↗ Method of use U-3186 Nov 12, 2041
US 10093697 ↗ Method of use U-3648 Nov 8, 2031
US 10093697 ↗ Method of use U-3648 Nov 8, 2031
US 10093697 ↗ Method of use U-3648 Nov 8, 2031
US 10093697 ↗ Method of use U-3648 Nov 8, 2031
US 10011633 ↗ Method of use U-3648 Nov 8, 2031
US 10011633 ↗ Method of use U-3648 Nov 8, 2031
US 10011633 ↗ Method of use U-3648 Nov 8, 2031
US 10011633 ↗ Method of use U-3648 Nov 8, 2031
US 9694018 ↗ Method of use U-3648 Mar 18, 2034
US 9694018 ↗ Method of use U-3648 Mar 18, 2034
US 9694018 ↗ Method of use U-3648 Mar 18, 2034
US 9694018 ↗ Method of use U-3648 Mar 18, 2034
US 11732006 ↗ Method of use U-3648 Nov 8, 2031
US 11732006 ↗ Method of use U-3648 Nov 8, 2031
US 11732006 ↗ Method of use U-3648 Nov 8, 2031
US 11732006 ↗ Method of use U-3648 Nov 8, 2031
US 11732006 ↗ Method of use U-3186 Nov 8, 2031
US 11732006 ↗ Method of use U-3186 Nov 8, 2031
US 11732006 ↗ Method of use U-3186 Nov 8, 2031
US 11732006 ↗ Method of use U-3186 Nov 8, 2031
US 12187812 ↗ Method of use U-3186 Nov 8, 2031
US 12187812 ↗ Method of use U-3186 Nov 8, 2031
US 12187812 ↗ Method of use U-3186 Nov 8, 2031
US 12187812 ↗ Method of use U-3186 Nov 8, 2031
US 12187812 ↗ Method of use U-3648 Nov 8, 2031
US 12187812 ↗ Method of use U-3648 Nov 8, 2031
US 12187812 ↗ Method of use U-3648 Nov 8, 2031
US 12187812 ↗ Method of use U-3648 Nov 8, 2031
US 11365182 ↗ Method of use U-3648 Jun 20, 2039
US 11365182 ↗ Method of use U-3648 Jun 20, 2039
US 11365182 ↗ Method of use U-3648 Jun 20, 2039
US 11365182 ↗ Method of use U-3648 Jun 20, 2039
US 10981952 ↗ Method of use U-3648 Nov 8, 2031
US 10981952 ↗ Method of use U-3649 Nov 8, 2031
US 10981952 ↗ Method of use U-3649 Nov 8, 2031
US 10981952 ↗ Method of use U-3648 Nov 8, 2031
US 10981952 ↗ Method of use U-3648 Nov 8, 2031
US 10981952 ↗ Method of use U-3649 Nov 8, 2031
US 10981952 ↗ Method of use U-3648 Nov 8, 2031
US 10981952 ↗ Method of use U-3649 Nov 8, 2031
US 10487111 ↗ Method of use U-3648 Nov 8, 2031
US 10487111 ↗ Method of use U-3648 Nov 8, 2031
US 10487111 ↗ Method of use U-3648 Nov 8, 2031
US 10487111 ↗ Method of use U-3648 Nov 8, 2031
US 11365182 ↗ Method of use U-3186 Jun 20, 2039
US 11365182 ↗ Method of use U-3186 Jun 20, 2039
US 11365182 ↗ Method of use U-3186 Jun 20, 2039
US 11365182 ↗ Method of use U-3186 Jun 20, 2039
US 11801226 ↗ Drug product — Jun 20, 2039
US 11801226 ↗ Drug product — Jun 20, 2039
US 11801226 ↗ Drug product — Jun 20, 2039
US 11802115 ↗ Drug product — Jun 20, 2039
US 12091394 ↗ Drug substance — Jun 20, 2039
US 11802115 ↗ Drug product — Jun 20, 2039
US 12091394 ↗ Drug substance — Jun 20, 2039
US 12091394 ↗ Drug substance — Jun 20, 2039
US 11802115 ↗ Drug product — Jun 20, 2039
US 10975046 ↗ Drug substance — Jun 20, 2039
US 10975046 ↗ Drug substance — Jun 20, 2039
US 10975046 ↗ Drug substance — Jun 20, 2039
US 12091394 ↗ Drug substance — Jun 20, 2039
US 10975046 ↗ Drug substance — Jun 20, 2039
US 11801226 ↗ Drug product — Jun 20, 2039
US 11802115 ↗ Drug product — Jun 20, 2039
FDA exclusivity
CodeWhat it grantsExpires
I-918New indication (3-year)Jun 13, 2026
NCENew Chemical Entity (5-year)Jul 20, 2026
ODE-363Orphan Drug Exclusivity (7-year)Jul 20, 2028
ODE-436Orphan Drug Exclusivity (7-year)Jun 13, 2030
I-918New indication (3-year)Jun 13, 2026
NCENew Chemical Entity (5-year)Jul 20, 2026
ODE-363Orphan Drug Exclusivity (7-year)Jul 20, 2028
ODE-436Orphan Drug Exclusivity (7-year)Jun 13, 2030
I-918New indication (3-year)Jun 13, 2026
NCENew Chemical Entity (5-year)Jul 20, 2026
ODE-363Orphan Drug Exclusivity (7-year)Jul 20, 2028
ODE-436Orphan Drug Exclusivity (7-year)Jun 13, 2030
I-918New indication (3-year)Jun 13, 2026
NCENew Chemical Entity (5-year)Jul 20, 2026
ODE-363Orphan Drug Exclusivity (7-year)Jul 20, 2028
ODE-436Orphan Drug Exclusivity (7-year)Jun 13, 2030
Common questions
Is there a generic version of BYLVAY 200 MCG PELLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BYLVAY 200 MCG PELLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 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.

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

Medicare Part D (outpatient prescription) spending for Bylvay — 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 Bylvay. 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
$2.83M
Claims incl. refills
21
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$134,905.66
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 Bylvay (this brand).

Top reported reactions

Pruritus92
Diarrhoea84
Liver Transplant29
Abdominal Pain Upper22
Abdominal Pain20
Hepatic Enzyme Increased20
Blood Bilirubin Increased19

Reporter sex

350 reports
Male · 53%
Female · 47%

Serious outcomes

Death16
Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 107 4
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
15054-3301-01 You're viewing this 1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE 2024-01-10 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 15054-3301-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 15054-3301-01, written without dashes as 15054330101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 15054-3301-01, the first segment (15054) is the labeler code FDA assigned to Ipsen Biopharmaceuticals, Inc.; the middle segment (3301) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Ipsen Biopharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ipsen Biopharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
🎯 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 191 words ▾

1 INDICATIONS AND USAGE BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis (PFIC) the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1.1 ) Limitation of Use : BYLVAY is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein. ( 12.5 , 14.1 ) Alagille Syndrome (ALGS) the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS).

( 1.2 )

1.1Progressive Familial Intrahepatic Cholestasis (PFIC) BYLVAY is indicated for the treatment of pruritus in patients 3 months of age and older with PFIC. Limitations of Use BYLVAY is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump (BSEP) protein [see Clinical Pharmacology (12.5) and Clinical Studies (14.1) ].

1.2Alagille Syndrome (ALGS) BYLVAY is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with ALGS.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage PFIC: Patients 3 months and older: 40 mcg/kg taken orally once daily. ( 2.1 ) If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily, not to exceed a daily dosage of 6 mg/day. ( 2.1 ) ALGS: Patients 12 months and older: 120 mcg/kg taken orally once daily.

( 2.2 ) Preparation and Administration Instructions Administer BYLVAY in the morning with a meal. ( 2.4 ) Do not crush or chew capsules. ( 2.4 ) See full prescribing information for preparation and administration instructions.

( 2.4 )

2.1Recommended Dosage for Progressive Familial Intrahepatic Cholestasis (PFIC) in Patients Aged 3 Months and Older The recommended dosage of BYLVAY is 40 mcg/kg taken orally once daily in the morning with a meal. Table 1 below shows the recommended once daily dosage by body weight. If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily not to exceed a daily dosage of 6 mg/day.

BYLVAY oral pellets are intended for use by patients weighing less than 19.5 kilograms. BYLVAY capsules are intended for use by patients weighing 19.5 kilograms or above. Table 1.

Recommended Dosage for PFIC in Patients aged 3 months and older (40 mcg/kg/day) Body Weight (kg) Once Daily Dosage (mcg) 7.4 and below 200 7.5 to 12.4 400 12.5 to 17.4 600 17.5 to 25.4 800 25.5 to 35.4 1,200 35.5 to 45.4 1,600 45.5 to 55.4 2,000 55.5 and above 2,400

2.2Recommended Dosage for Alagille Syndrome (ALGS) in Patients Aged 12 Months and Older The recommended dosage of BYLVAY is 120 mcg/kg taken orally once daily in the morning with a meal. Table 2 below shows the recommended once daily dosage by body weight. BYLVAY oral pellets are intended for use by patients weighing less than 19.5 kilograms.

BYLVAY capsules are intended for use by patients weighing 19.5 kilograms or above. Table 2. Recommended Dosage for ALGS in Patients aged 12 months and older (120 mcg/kg/day) Body Weight (kg) Once Daily Dosage (mcg) 7.4 and below 600 7.5 to 12.4 1,200 12.5 to 17.4 1,800 17.5 to 25.4 2,400 25.5 to 35.4 3,600 35.5 to 45.4 4,800 45.5 to 55.4 6,000 55.5 and above 7,200

2.3Dosage Modification for Management of Adverse Reactions Tolerability for Alagille Syndrome (ALGS) Dose reduction to 40 mcg/kg/day (Table 1) may be considered if tolerability issues occur in the absence of other causes. Once tolerability issues stabilize, increase to 120 mcg/kg/day. Liver Test Abnormalities Establish the baseline pattern of variability of liver tests prior to starting BYLVAY, so that potential signs of liver injury can be identified.

Monitor liver tests (e.g., ALT [alanine aminotransferase], AST [aspartate aminotransferase], TB [total bilirubin], DB [direct bilirubin] and International Normalized Ratio [INR]) during treatment with BYLVAY. Interrupt BYLVAY if new onset liver test abnormalities occur or symptoms consistent with clinical hepatitis are observed [see Warnings and Precautions (5.1) ]. Once the liver test abnormalities either return to baseline values or stabilize at a new baseline value, consider restarting BYLVAY at the recommended dosage [see Dosage and Administration (2.1 , 2.2) ] .

Consider discontinuing BYLVAY permanently if liver test abnormalities recur. Discontinue BYLVAY permanently if a patient experiences a hepatic decompensation event (e.g., variceal hemorrhage, ascites, hepatic encephalopathy).

2.4Preparation and Administration Instructions For patients taking bile acid binding resins, take BYLVAY at least 4 hours before or 4 hours after taking a bile acid binding resin [see Drug Interactions (7.1) ]. Do not crush or chew capsules. Oral Pellets: Mix the contents of the shell containing Oral Pellets into soft food or a liquid (as described below).

Discard the emptied shells. Do not let your child swallow the unopened shells containing the Oral Pellets. Administration Instructions for pati…

💊 Dosage Forms and Strengths 83 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Pellets: 200 mcg: capsule with ivory opaque cap and white opaque body; imprinted "A200" (black ink). 600 mcg: capsule with ivory opaque cap and body; imprinted "A600" (black ink). Capsules: 400 mcg: capsule with medium orange opaque cap and white opaque body; imprinted "A400" (black ink).

1200 mcg: capsule with medium orange opaque cap and body; imprinted "A1200" (black ink). Oral Pellets: 200 mcg, 600 mcg ( 3 ) Capsules: 400 mcg, 1200 mcg ( 3 )

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS IBAT inhibitors, including BYLVAY, are contraindicated in patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) [see Warnings and Precautions (5.1) ] . Patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy). ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatoxicity : Obtain baseline liver tests and monitor patients frequently for the first 6 to 8 months after starting therapy, and as clinically indicated thereafter during treatment. If liver test abnormalities or signs of clinical hepatitis occur, consider dose reduction or treatment interruption. For persistent or recurrent liver test abnormalities relative to baseline, discontinue BYLVAY.

Monitor patients with compensated cirrhosis or portal hypertension more frequently. Permanently discontinue BYLVAY if hepatic decompensation occurs. ( 2.3 , 5.1 ) Diarrhea : Treat dehydration.

Treatment interruption or discontinuation may be required for persistent diarrhea. ( 5.2 ) Fat-Soluble Vitamin (FSV) Deficiency : Obtain baseline levels and monitor during treatment. Supplement with FSV if deficiency is observed.

If FSV deficiency persists or worsens despite FSV supplementation, consider discontinuing BYLVAY treatment. Fracture: Consider interrupting BYLVAY treatment. Supplement with FSV if indicated.

Bleeding: Interrupt treatment with BYLVAY. Optimize treatment of FSV deficiency and consider restarting BYLVAY once the patient is clinically stable. ( 5.3 )

5.1Hepatoxicity BYLVAY treatment is associated with a potential for drug-induced liver injury (DILI). In the PFIC and ALGS trials, treatment-emergent elevations of liver tests or worsening of liver tests occurred. Of the six patients who experienced DILI, two underwent liver transplant.

Obtain baseline liver tests because some ALGS and PFIC patients have abnormal liver tests at baseline. Monitor patients frequently for the first 6 to 8 months after starting therapy and as clinically indicated thereafter during treatment with BYLVAY. Monitor for elevation in liver tests, for the development of liver-related adverse reactions, and for physical signs of hepatic decompensation.

If liver test abnormalities or signs of clinical hepatitis occur in the absence of other causes, consider dose reduction or treatment interruption. Permanently discontinue BYLVAY if a patient experiences the following: persistent or recurrent liver test abnormalities, or upon rechallenge, signs and symptoms consistent with clinical hepatitis, or a hepatic decompensation event. The safety and effectiveness of BYLVAY have not been established in patients with decompensated cirrhosis.

Monitor patients with compensated cirrhosis or portal hypertension more frequently and discontinue BYLVAY if hepatic decompensation occurs. IBAT inhibitors, including BYLVAY, are contraindicated in patients with prior or active hepatic decompensation events [see Contraindications (4) ] .

5.2Diarrhea In Trial 1, diarrhea in PFIC patients was reported in 2 (10%) placebo-treated patients, 9 (39%) BYLVAY-treated 40 mcg/kg/day patients and 4 (21%) BYLVAY-treated 120 mcg/kg/day patients. Treatment interruption due to diarrhea occurred in 2 patients with 3 events during treatment with BYLVAY 120 mcg/kg/day. Treatment interruption due to diarrhea ranged between 3 to 7 days [see Adverse Reactions (6.1) ] .

One patient treated with BYLVAY 120 mcg/kg/day withdrew from Trial 1 due to persistent diarrhea. In Trial 3, diarrhea in ALGS patients was reported in 1 placebo-treated patient (6%) and in 10 (29%) BYLVAY-treated patients [see Adverse Reactions (6.1) ] . No patients interrupted or permanently discontinued BYLVAY due to diarrhea.

If diarrhea occurs, monitor for dehydration and treat promptly. Interrupt BYLVAY dosing if a patient experiences persistent diarrhea. Restart BYLVAY at 40 mcg/kg/day when diarrhea resolves, and increase the dose as tolerated if appropriate.

If diarrhea persists and no alternate etiology is identified, stop BYLVAY treatment.

5.3Fat-Soluble Vitamin Deficiency BYLVAY may adversely affect absorption of fat-soluble vitamins (FSV). FSV include vitamin A, D, E, and K (measured using INR levels). PFIC and ALGS patients can have FSV deficiency at baseline and are frequently supplemented with FSV…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Hepatotoxicity [ see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Fat-Soluble Vitamin Deficiency [see Warnings and Precautions (5.3) ] PFIC: Most common adverse reactions (>2%) are liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency. ( 6.1 ) ALGS: Most common adverse reactions (>5%) are diarrhea, abdominal pain, hematoma, and decreased weight.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127, 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. PFIC Clinical Studies Trial 1 is a randomized, double-blind, placebo-controlled, 24-week study of two dose levels of BYLVAY (40 mcg/kg and 120 mcg/kg) administered once daily [see Clinical Studies (14.1) ] . Sixty-two patients were randomized (1:1:1) to receive one of the following: BYLVAY 40 mcg/kg/day (n=23), BYLVAY 120 mcg/kg/day (n=19), or Placebo (n=20).

Table 3 summarizes the frequency of adverse reactions reported in ≥2% and at a rate greater than placebo in patients treated with BYLVAY in Trial 1. The most common adverse reactions observed in Trial 1 included diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency. Table 3.

Common Adverse Reactions Adverse reactions that occurred in ≥2% of BYLVAY-treated patients from a Clinical Study of BYLVAY in Patients with Progressive Familial Intrahepatic Cholestasis (Trial 1) Adverse Reaction Placebo N=20 n (%) BYLVAY 40 mcg/kg/day N=23 n (%) BYLVAY 120 mcg/kg/day N=19 n (%) Diarrhea 2 (10%) 9 (39%) 4 (21%) Transaminases increased (ALT, AST) 1 (5%) 3 (13%) 4 (21%) Vomiting 0 4 (17%) 3 (16%) Abdominal pain 0 3 (13%) 3 (16%) Blood bilirubin increased 2 (10%) 3 (13%) 2 (11%) Fat-soluble vitamin deficiency (A, D, E) 1 (5%) 0 3 (16%) Splenomegaly 0 0 2 (11%) Cholelithiasis 0 0 1 (5%) Dehydration 0 0 1 (5%) Fracture 0 1 (4%) 0 Trial 2 is an open-label, single-arm study in 116 patients with PFIC types 1, 2, 3, 4 and 6; four patients with benign recurrent intrahepatic cholestasis (BRIC) were also enrolled.

BYLVAY 40 or 120 mcg/kg/day was administered once daily for 72 weeks, with the option to continue treatment beyond 72 weeks. Adverse reactions were similar to those observed in Trial 1. However, fractures were reported in a total of 6 patients (5%) in Trial 2.

Adverse reactions observed in Trial 2 in addition to those described in Table 3 included increased INR (16%), epistaxis (9%), constipation (8%), coagulopathy (3%), headache (3%), nausea (3%), rash (3%), iron deficiency anemia (3%), gastroesophageal reflux disease (2%), prolonged prothrombin time (2%); and variceal hemorrhage, stoma hemorrhage, hematochezia, and rectal hemorrhage (<1% each). Adverse reactions leading to treatment discontinuation were increased bilirubin levels, diarrhea, progression of disease, increased INR, irritability, and decreased weight.

There was a total of 19 (16%) patients who underwent surgical intervention in Trial 2, with one patient who had surgical biliary diversion (SBD) followed by liver transplant, 15 patients who underwent liver transplant alone, and three patients who underwent SBD alone. Overall, 11 of the 19 patients had these surgical interventions prior to Week 72. ALGS Clinical Studies Trial 3 is a randomized, double-blind, placebo-controlled, 24-week study of a single dose level of BYLVAY (120 mcg/kg) administered once daily [see Clinical Studies (14.2) ] .

Fifty-two patients were randomized (2:1) to receive one of the following: BYLVAY 120 mcg/kg/day (n=35), or Placebo (n=1…

🔄 Drug Interactions 52 words ▾

7 DRUG INTERACTIONS

7.1Bile Acid Binding Resins Administer bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol) at least 4 hours before or 4 hours after administration of BYLVAY [see Dosage and Administration (2.3) ] . Bile acid binding resins may bind odevixibat in the gut, which may reduce BYLVAY efficacy.

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Limited human data on the use of BYLVAY in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. Based on findings from animal reproduction studies, BYLVAY may cause cardiac malformations when a fetus is exposed during pregnancy. In pregnant rabbits treated orally with odevixibat during organogenesis, an increased incidence of malformations in fetal heart, great blood vessels, and other vascular sites occurred at all doses; maternal systemic exposure at the lowest dose was 2.1 times the maximum recommended dose (see Data ) .

Odevixibat may inhibit the absorption of fat-soluble vitamins. FSV are essential for normal fetal growth and development. Monitor pregnant patients for FSV deficiency and supplement as needed.

Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) and Clinical Considerations ] . Consider the woman's need for BYLVAY, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal PFIC and ALGS. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy safety study that monitors pregnancy outcomes in women exposed to BYLVAY during pregnancy. Pregnant women exposed to BYLVAY, or their healthcare providers, should report BYLVAY exposure by calling 1-855-463-5127.

Clinical Considerations Fetal/Neonatal Adverse Reactions Odevixibat may inhibit the absorption of fat-soluble vitamins (FSV). Monitor pregnant patients for FSV deficiency and supplement as needed. Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) ].

Data Animal Data In an embryo-fetal development study, pregnant rabbits received oral doses of 10, 30, or 100 mg/kg/day during the period of organogenesis. Fetuses from all maternal groups treated with odevixibat showed an increase in cardiovascular malformations, which included 5-chambered heart, small ventricle, large atrium, ventricular septum defect, misshapen aortic valve, dilated aortic arch, right sided and retroesophageal aortic arch, fusion of aortic arch and pulmonary trunk, ductus arteriosus atresia, and absence of subclavian artery.

These malformations occurred at 2.1 times the maximum recommended dose and higher, based on AUC (area under the plasma concentration-time curve). Odevixibat was shown to cross the placenta in pregnant rats. No adverse effects on embryo-fetal development were observed following oral administration of 100, 300, or 1,000 mg/kg/day in pregnant rats during organogenesis.

An increase in skeletal variations (delayed/incomplete ossification and thick ribs) was observed at 1,000 mg/kg/day. Maternal systemic exposure to odevixibat at the maximum dose tested was 272 times the maximum recommended dose, based on AUC. No adverse effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with up to 1,000 mg/kg/day during organogenesis through lactation.

The maternal AUC for odevixibat at 1,000 mg/kg/day was 434 times the maximum recommended dose, based on AUC.

8.2Lactation Risk Summary Odevixibat has low absorption following oral administration, and exposure of the infant to BYLVAY through breast milk is not expected at the recommended doses [see Clinical Pharmacology (12.3) ]. There are no data on the presence of odevixibat in human milk, the effects on the breastfed infant, or the effects on milk production. BYLVAY may reduce absorption of fat-soluble vitamins [see Warning and Precautions (5.3) ] .

Monitor FSV le…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited human data on the use of BYLVAY in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. Based on findings from animal reproduction studies, BYLVAY may cause cardiac malformations when a fetus is exposed during pregnancy. In pregnant rabbits treated orally with odevixibat during organogenesis, an increased incidence of malformations in fetal heart, great blood vessels, and other vascular sites occurred at all doses; maternal systemic exposure at the lowest dose was 2.1 times the maximum recommended dose (see Data ) .

Odevixibat may inhibit the absorption of fat-soluble vitamins. FSV are essential for normal fetal growth and development. Monitor pregnant patients for FSV deficiency and supplement as needed.

Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) and Clinical Considerations ] . Consider the woman's need for BYLVAY, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal PFIC and ALGS. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy safety study that monitors pregnancy outcomes in women exposed to BYLVAY during pregnancy. Pregnant women exposed to BYLVAY, or their healthcare providers, should report BYLVAY exposure by calling 1-855-463-5127.

Clinical Considerations Fetal/Neonatal Adverse Reactions Odevixibat may inhibit the absorption of fat-soluble vitamins (FSV). Monitor pregnant patients for FSV deficiency and supplement as needed. Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) ].

Data Animal Data In an embryo-fetal development study, pregnant rabbits received oral doses of 10, 30, or 100 mg/kg/day during the period of organogenesis. Fetuses from all maternal groups treated with odevixibat showed an increase in cardiovascular malformations, which included 5-chambered heart, small ventricle, large atrium, ventricular septum defect, misshapen aortic valve, dilated aortic arch, right sided and retroesophageal aortic arch, fusion of aortic arch and pulmonary trunk, ductus arteriosus atresia, and absence of subclavian artery.

These malformations occurred at 2.1 times the maximum recommended dose and higher, based on AUC (area under the plasma concentration-time curve). Odevixibat was shown to cross the placenta in pregnant rats. No adverse effects on embryo-fetal development were observed following oral administration of 100, 300, or 1,000 mg/kg/day in pregnant rats during organogenesis.

An increase in skeletal variations (delayed/incomplete ossification and thick ribs) was observed at 1,000 mg/kg/day. Maternal systemic exposure to odevixibat at the maximum dose tested was 272 times the maximum recommended dose, based on AUC. No adverse effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with up to 1,000 mg/kg/day during organogenesis through lactation.

The maternal AUC for odevixibat at 1,000 mg/kg/day was 434 times the maximum recommended dose, based on AUC.

🧒 Pediatric Use 210 words ▾

8.4Pediatric Use The safety and effectiveness of BYLVAY have been established in pediatric patients 3 months to 17 years of age for the treatment of pruritus in PFIC. Use of BYLVAY in this age group is supported by evidence from one randomized, double-blind, placebo-controlled trial conducted in 62 patients with a confirmed diagnosis of PFIC type 1 or type 2 (Trial 1), and an open-label extension trial in PFIC patients (Trial 2) [see Adverse Reactions (6.1) and Clinical Studies (14.1) ] . The safety and effectiveness of BYLVAY for the treatment of pruritus in PFIC in pediatric patients less than 3 months of age have not been established.

The safety and effectiveness of BYLVAY have been established in pediatric patients 12 months to 17 years of age for the treatment of pruritus in ALGS. Use of BYLVAY in this age group is supported by evidence from one randomized, double-blind, placebo-controlled trial conducted in 52 patients with a confirmed diagnosis of ALGS (Trial 3) and one open-label extension trial in ALGS patients (Trial 4) [see Adverse Reactions (6.1) and Clinical Studies (14.2) ] . The safety and effectiveness of BYLVAY for the treatment of pruritus in ALGS in pediatric patients less than 12 months of age have not been established.

🧓 Geriatric Use 29 words ▾

8.5Geriatric Use PFIC and ALGS are largely diseases of pediatric and young adult patients. Clinical studies in BYLVAY did not include patients 65 years of age and older.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum . Pruritus is a common symptom in patients with PFIC and ALGS; the pathophysiology of pruritus in patients with PFIC is not completely understood.

Although the complete mechanism by which odevixibat improves pruritus in both PFIC and ALGS patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids [see Clinical Pharmacology (12.2) ] .

12.2Pharmacodynamics Odevixibat reduces serum bile acids in patients with PFIC and ALGS . In Trial 1, a 24-week, randomized, double-blind, placebo-controlled trial conducted in 62 patients with a confirmed diagnosis of PFIC type 1 or type 2, the majority of patients (88.7%) had elevated serum bile acids above 100 mcmol/L at baseline [see Clinical Studies (14.1) ] . Serum bile acids concentrations were reduced from baseline within 4-8 weeks of odevixibat treatment compared to placebo treatment.

The decreased concentrations of serum bile acids fluctuated over time but generally were maintained during the treatment over 24 weeks. The extent of decrease in serum bile acids was similar between 40 and 120 mcg/kg. Trial 3 is a 24-week, randomized, double-blind, placebo-controlled trial conducted in 52 patients with a confirmed diagnosis of ALGS who were administered treatment with BYLVAY 120 mcg/kg once daily [see Clinical Studies (14.2) ].

At baseline, serum bile acids were variable ranging from 93 to 510 mcmol/L. Serum bile acid concentrations were reduced from baseline as early as Week 4 of odevixibat treatment and the reduction was generally maintained during treatment over 24 weeks.

12.3Pharmacokinetics In pediatric patients with PFIC, 6 months to 17 years of age who received BYLVAY 40 mcg/kg or 120 mcg/kg once daily with food in the morning, the measurable odevixibat concentrations ranged from 0.06 to 0.72 ng/mL, and odevixibat concentrations were below the limit of quantification (0.05 ng/mL) in the majority of plasma samples. In pediatric patients with ALGS who received BYLVAY 120 mcg/kg once daily with food in the morning, the measurable odevixibat concentrations ranged from 0.05 to 3.4 ng/mL.

Following single and repeated oral administration of odevixibat from 0.1 to 3 mg in healthy adults, plasma concentrations of odevixibat were mostly below the limit of quantification (0.05 ng/mL); therefore, AUC and peak plasma concentration (C max ) could not be calculated. Following a single administration of odevixibat 7.2 mg in healthy adults, the mean (%CV) C max and AUC 0-24h were 0.47 ng/mL (34.8) and 2.19 ng∙h/mL (36.2), respectively. No accumulation of odevixibat was observed following once-daily dosing.

Absorption Odevixibat is minimally absorbed following oral administration. Following a single administration of odevixibat 7.2 mg in healthy adults, odevixibat C max is reached between 1 to 5 hours. Sprinkle on Applesauce When odevixibat 9.6 mg was administered after sprinkling the pellets on applesauce, decreases of 39% and 35% in C max and AUC 0-24h , respectively, and delayed median T max from 3 hours to 4.5 hours were observed compared to administration of whole capsules (eight 1200 mcg capsules) under fasted conditions.

The effect of sprinkling on soft food on systemic exposure is not clinically significant [see Dosage and Administration (2.3) ]. Effect of Food Concomitant administration of a high-fat meal (800-1000 calories with approximately 50% of total caloric content of the meal from fat) with a single dose of odevixibat 9.6 mg delayed median T max from 3 hours to 4.5 hours and resulted in decreases of 72% and 62% in C max and AUC 0-24h , respectively, compared to administration under fasted conditions in healthy adults. The effect of food on the changes of systemic exp…

🧬 Mechanism of Action 102 words ▾

12.1Mechanism of Action Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum . Pruritus is a common symptom in patients with PFIC and ALGS; the pathophysiology of pruritus in patients with PFIC is not completely understood.

Although the complete mechanism by which odevixibat improves pruritus in both PFIC and ALGS patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids [see Clinical Pharmacology (12.2) ] .

📦 How Supplied / Storage and Handling 154 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Oral Pellets 200 mcg Oral Pellets: supplied as Size 0 capsule with ivory opaque cap and white opaque body; imprinted "A200" (black ink). Supplied in bottles of 30 with child-resistant closure (NDC 15054-3301-1). 600 mcg Oral Pellets: supplied as Size 0 capsule with ivory opaque cap and body; imprinted "A600" (black ink).

Supplied in bottles of 30 with child-resistant closure (NDC 15054-3303-1). Capsules 400 mcg Capsule: supplied as Size 3 capsule with medium orange opaque cap and white opaque body; imprinted "A400" (black ink). Supplied in bottles of 30 with child-resistant closure (NDC 15054-3302-1).

1,200 mcg Capsule: supplied as Size 3 capsule with medium orange opaque cap and body; imprinted "A1200" (black ink). Supplied in bottles of 30 with child-resistant closure (NDC 15054-3304-1). Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 26 words ▾

Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature].

📋 Description 175 words ▾

11 DESCRIPTION The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ 6 ,2,5-benzothiadiazepin-8yl]oxy}acetamido)-2-(4-hydroxyphenyl)acetly]amino}butanoic acid, which is formulated as the sesquihydrate having the following chemical structure: The molecular formula is C 37 H 48 N 4 O 8 S 2 ×

1.5H 2 O, with a molecular weight of 768.0 g/mol (anhydrous 740.9 g/mol). Odevixibat sesquihydrate is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and increases with increased pH.

BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose. The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide. The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide.

The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Administration Instructions Advise patients or their caregivers(s) to: Take BYLVAY in the morning with a meal. Do not swallow the 200 mcg or 600 mcg capsule(s) containing Oral Pellets whole.

These are intended to be opened and the contents mixed into soft food or liquids [see Dosage and Administration (2.1 , 2.2 , 2.4) ] . Follow stepwise administration Instructions [see Dosage and Administration (2.4) ] for Oral Pellets and Capsules for patients unable to swallow the capsules whole. Take BYLVAY at least 4 hours before or 4 hours after taking a bile acid binding resin (e.g., cholestyramine, colesevelam, or colestipol) [see Drug Interactions (7.1) ].

Hepatotoxicity Advise patients or their caregiver(s) that liver tests should be obtained before starting BYLVAY and periodically during BYLVAY therapy. Inform patients or their caregiver(s) of the potential risk of hepatotoxicity, and that they will need to undergo monitoring for liver injury. Instruct patients or their caregiver(s) to immediately report any signs or symptoms of severe liver injury to their healthcare provider [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ].

Diarrhea Advise patients or their caregiver(s) to notify their healthcare provider if they experience new onset or worsening of diarrhea [see Warnings and Precautions (5.2) ]. Fat Soluble Vitamin (FSV) Deficiency Advise patients or their caregiver(s) that INR (for vitamin K) and serum levels of vitamins A, D, E will be obtained before starting and periodically during treatment to assess for FSV deficiency [see Warnings and Precautions (5.3) ]. Inform patients or their caregiver(s) that they may bleed more easily, may bleed longer, or have a bone fracture.

Advise patients or their caregiver(s) to call their healthcare provider for any signs or symptoms of bleeding or report any fractures. Pregnancy Advise patients or their caregiver(s) that there is a pregnancy safety study that collects pregnancy outcome data in women taking BYLVAY during pregnancy. Pregnant women exposed to BYLVAY, or their healthcare providers, should report BYLVAY exposure by calling 1-855-463-5127 [see Use in Specific Populations (8.1) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 15054-1120-04 · Ipsen 15054-3302-01 · Ipsen →
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.