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FANAPT ILOPERIDONE Kit, 1 dose — NDC 43068-0113-04 package photo

FANAPT ILOPERIDONE Kit, 1 dose

by Vanda Pharmaceuticals Inc. · 1 BLISTER PACK in 1 DOSE PACK (43068-113-04) / 1 KIT in 1 BLISTER PACK
NDC 43068-0113-04
🏷️ FDA NDC (as labeled) 43068-113-04 billing pads the product 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) 43068-113-04
Product NDC 43068-113
11-digit billing NDC 43068011304
NCPDP billing unit EA — each (per item)
RxCUI 848722, 848726, 848728, 848730, 848732, 848734, 848736, 848738,
UNII VPO7KJ050N
UPC 0343068108029, 0343068110022, 0343068101020, 0343068106025 +3 more
Application # NDA022192
SPL Set ID 33f60b40-3fca-11de-8f56-0002a5d5c51b
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-12-01
Route ORAL
Dosage form KIT
GPI-14 59070035006320
GPI class Fanapt Titration Pack
GCN Seq No 065908
GCN 28034
HICL code 036778
Ingredient (HICL) Iloperidone
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7T
Therapeutic class — specific (HIC3) Antipsychotic,Atypical,Dopamine,Serotonin Antagnst
AHFS code 28:16.08.04
AHFS class Atypical Antipsychotics
FDB label name FANAPT TITRATION PACK A
FDB brand name Fanapt
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 43068-113-04 — 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 → 43068-0113-04. 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 Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Other antipsychotics
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

LabelerVanda Pharmaceuticals Inc.
Application holderVANDA PHARMACEUTICALS INC
FDA applicationNDA022192 (NDA)
Labeler code43068
First marketedDec 2015
Product typeHuman Prescription Drug
Portfolio38 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 FANAPT TITRATION PACK A Ingredient Iloperidone
📖 What it is MedlinePlus · NLM

Iloperidone is used to treat the symptoms of schizophrenia (a mental illness that affects how a person thinks, feels and behaves) and bipolar I disorder (a disease that causes depression, mania, and other abnormal moods). Iloperidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Iloperidone tablets are approved to treat schizophrenia in adults. If you've been prescribed the brand Fanapt, it has one additional approved use: treating acute manic or mixed epi...
  • Iloperidone can cause a significant drop in blood pressure when you first start it — especially when you stand up quickly — which can make you dizzy or even faint. That's called or...
  • Why do I have to start on such a small dose and increase it slowly?
  • The most common side effects include dizziness (especially when standing), drowsiness, dry mouth, a fast heartbeat, nasal congestion, fatigue, and some weight gain. Most of these e...
📖 Read our full Iloperidone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeRound
Imprint8
Size1 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.

The FDA label contains product information, but this exact NDC could not be matched safely to one product block. We intentionally withheld sibling strengths’ ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $257.59 $257.59 / 1 kit
Medicare drug plans payPart D · Q2 2026 $31.96 $31.96 / 1 kit
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
Fanaptthis 43068-0113-04 Vanda 1 dose — — FDA listed —
Fanapt 43068-0115-04 Vanda 1 dose — — FDA listed —
Fanapt 43068-0907-12 Vanda 1 dose — — FDA listed —
Fanapt 43068-0114-03 Vanda 1 dose — — FDA listed —
Fanapt 43068-0903-08 Vanda 1 dose — — FDA listed —
Fanapt 43068-0906-08 Vanda 1 dose — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2009
First FDA approval
May 2009
📍
2026
Currently FDA-listed
17 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 6, 2009 RLD RS ⏳ ~5.3 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 8586610 — method of use (U-1625)
US 8586610 — method of use (U-1625)
US 8586610 — method of use (U-1625)
US 8586610 — method of use (U-1625)
US 8586610 — method of use (U-1625)
US 9074256 — method of use (U-1674)
US 9072742 — method of use (U-1674)
US 9072742 — method of use (U-1674)
US 9074256 — method of use (U-1674)
US 9072742 — method of use (U-1674)
US 9074256 — method of use (U-1674)
US 9074256 — method of use (U-1674)
US 9072742 — method of use (U-1674)
US 9074255 — method of use (U-1674)
US 9072742 — method of use (U-1674)
US 9157121 — method of use (U-1674)
US 9157121 — method of use (U-1674)
US 9157121 — method of use (U-1674)
US 9157121 — method of use (U-1674)
US 8999638 — method of use (U-1674)
US 8999638 — method of use (U-1674)
US 8999638 — method of use (U-1674)
US 9074254 — method of use (U-1674)
US 9074254 — method of use (U-1674)
US 9074254 — method of use (U-1674)
US 8652776 — method of use (U-1685)
US 8652776 — method of use (U-1685)
US 9074255 — method of use (U-1674)
US 9072742 — method of use (U-1674)
US 9074255 — method of use (U-1674)
US 9072742 — method of use (U-1674)
US 9157121 — method of use (U-1674)
US 8999638 — method of use (U-1674)
US 8999638 — method of use (U-1674)
US 9074254 — method of use (U-1674)
US 9074254 — method of use (U-1674)
US 8652776 — method of use (U-1685)
US 8652776 — method of use (U-1685)
US 8652776 — method of use (U-1685)
US 8652776 — method of use (U-1685)
US 9074255 — method of use (U-1674)
US 9157121 — method of use (U-1674)
US 8586610 — method of use (U-1625)
US 9074254 — method of use (U-1674)
US 9074254 — method of use (U-1674)
US 9074255 — method of use (U-1674)
US 9074255 — method of use (U-1674)
US 9074255 — method of use (U-1674)
US 9074256 — method of use (U-1674)
US 9157121 — method of use (U-1674)
US 9074256 — method of use (U-1674)
US 8652776 — method of use (U-1685)
US 8999638 — method of use (U-1674)
US 8999638 — method of use (U-1674)
US 9074256 — method of use (U-1674)
US 8586610 — method of use (U-1625)
US 12606869 — method of use (U-4504)
US 12606869 — method of use (U-4505)
US 12606869 — method of use (U-4504)
US 12606869 — method of use (U-4505)
US 12606869 — method of use (U-4504)
US 12606869 — method of use (U-4505)
US 12606869 — method of use (U-4504)
US 12606869 — method of use (U-4505)
US 12606869 — method of use (U-4504)
US 12606869 — method of use (U-4505)
US 12606869 — method of use (U-4504)
US 12606869 — method of use (U-4505)
US 12606869 — method of use (U-4504)
US 12606869 — method of use (U-4505)
US 10570453 — method of use (U-4562)
US 10570453 — method of use (U-4563)
US 10570453 — method of use (U-4562)
US 10570453 — method of use (U-4563)
US 10570453 — method of use (U-4562)
US 10570453 — method of use (U-4563)
US 10570453 — method of use (U-4562)
US 10570453 — method of use (U-4563)
US 10570453 — method of use (U-4562)
US 10570453 — method of use (U-4563)
US 10570453 — method of use (U-4562)
US 10570453 — method of use (U-4563)
US 10570453 — method of use (U-4562)
US 10570453 — method of use (U-4563)
US 10563259 — method of use (U-4562)
US 10563259 — method of use (U-4563)
US 10563259 — method of use (U-4562)
US 10563259 — method of use (U-4563)
US 10563259 — method of use (U-4562)
US 10563259 — method of use (U-4563)
US 10563259 — method of use (U-4562)
US 10563259 — method of use (U-4563)
US 10563259 — method of use (U-4562)
US 10563259 — method of use (U-4563)
US 10563259 — method of use (U-4562)
US 10563259 — method of use (U-4563)
US 10563259 — method of use (U-4562)
US 10563259 — method of use (U-4563)
Exclusivity I-939
Exclusivity I-939
Exclusivity I-939
Exclusivity I-939
Exclusivity I-939
Exclusivity I-939
Exclusivity I-939
2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
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 (98)
PatentTypeUse codeExpires
US 8586610 ↗ Method of use U-1625 Nov 2, 2027
US 8586610 ↗ Method of use U-1625 Nov 2, 2027
US 8586610 ↗ Method of use U-1625 Nov 2, 2027
US 8586610 ↗ Method of use U-1625 Nov 2, 2027
US 8586610 ↗ Method of use U-1625 Nov 2, 2027
US 9074256 ↗ Method of use U-1674 Feb 10, 2031
US 9072742 ↗ Method of use U-1674 Jan 16, 2031
US 9072742 ↗ Method of use U-1674 Jan 16, 2031
US 9074256 ↗ Method of use U-1674 Feb 10, 2031
US 9072742 ↗ Method of use U-1674 Jan 16, 2031
US 9074256 ↗ Method of use U-1674 Feb 10, 2031
US 9074256 ↗ Method of use U-1674 Feb 10, 2031
US 9072742 ↗ Method of use U-1674 Jan 16, 2031
US 9074255 ↗ Method of use U-1674 Dec 17, 2030
US 9072742 ↗ Method of use U-1674 Jan 16, 2031
US 9157121 ↗ Method of use U-1674 Apr 5, 2030
US 9157121 ↗ Method of use U-1674 Apr 5, 2030
US 9157121 ↗ Method of use U-1674 Apr 5, 2030
US 9157121 ↗ Method of use U-1674 Apr 5, 2030
US 8999638 ↗ Method of use U-1674 Oct 28, 2030
US 8999638 ↗ Method of use U-1674 Oct 28, 2030
US 8999638 ↗ Method of use U-1674 Oct 28, 2030
US 9074254 ↗ Method of use U-1674 Dec 28, 2031
US 9074254 ↗ Method of use U-1674 Dec 28, 2031
US 9074254 ↗ Method of use U-1674 Dec 28, 2031
US 8652776 ↗ Method of use U-1685 Aug 31, 2030
US 8652776 ↗ Method of use U-1685 Aug 31, 2030
US 9074255 ↗ Method of use U-1674 Dec 17, 2030
US 9072742 ↗ Method of use U-1674 Jan 16, 2031
US 9074255 ↗ Method of use U-1674 Dec 17, 2030
US 9072742 ↗ Method of use U-1674 Jan 16, 2031
US 9157121 ↗ Method of use U-1674 Apr 5, 2030
US 8999638 ↗ Method of use U-1674 Oct 28, 2030
US 8999638 ↗ Method of use U-1674 Oct 28, 2030
US 9074254 ↗ Method of use U-1674 Dec 28, 2031
US 9074254 ↗ Method of use U-1674 Dec 28, 2031
US 8652776 ↗ Method of use U-1685 Aug 31, 2030
US 8652776 ↗ Method of use U-1685 Aug 31, 2030
US 8652776 ↗ Method of use U-1685 Aug 31, 2030
US 8652776 ↗ Method of use U-1685 Aug 31, 2030
US 9074255 ↗ Method of use U-1674 Dec 17, 2030
US 9157121 ↗ Method of use U-1674 Apr 5, 2030
US 8586610 ↗ Method of use U-1625 Nov 2, 2027
US 9074254 ↗ Method of use U-1674 Dec 28, 2031
US 9074254 ↗ Method of use U-1674 Dec 28, 2031
US 9074255 ↗ Method of use U-1674 Dec 17, 2030
US 9074255 ↗ Method of use U-1674 Dec 17, 2030
US 9074255 ↗ Method of use U-1674 Dec 17, 2030
US 9074256 ↗ Method of use U-1674 Feb 10, 2031
US 9157121 ↗ Method of use U-1674 Apr 5, 2030
US 9074256 ↗ Method of use U-1674 Feb 10, 2031
US 8652776 ↗ Method of use U-1685 Aug 31, 2030
US 8999638 ↗ Method of use U-1674 Oct 28, 2030
US 8999638 ↗ Method of use U-1674 Oct 28, 2030
US 9074256 ↗ Method of use U-1674 Feb 10, 2031
US 8586610 ↗ Method of use U-1625 Nov 2, 2027
US 12606869 ↗ Method of use U-4504 Sep 22, 2030
US 12606869 ↗ Method of use U-4505 Sep 22, 2030
US 12606869 ↗ Method of use U-4504 Sep 22, 2030
US 12606869 ↗ Method of use U-4505 Sep 22, 2030
US 12606869 ↗ Method of use U-4504 Sep 22, 2030
US 12606869 ↗ Method of use U-4505 Sep 22, 2030
US 12606869 ↗ Method of use U-4504 Sep 22, 2030
US 12606869 ↗ Method of use U-4505 Sep 22, 2030
US 12606869 ↗ Method of use U-4504 Sep 22, 2030
US 12606869 ↗ Method of use U-4505 Sep 22, 2030
US 12606869 ↗ Method of use U-4504 Sep 22, 2030
US 12606869 ↗ Method of use U-4505 Sep 22, 2030
US 12606869 ↗ Method of use U-4504 Sep 22, 2030
US 12606869 ↗ Method of use U-4505 Sep 22, 2030
US 10570453 ↗ Method of use U-4562 Mar 28, 2028
US 10570453 ↗ Method of use U-4563 Mar 28, 2028
US 10570453 ↗ Method of use U-4562 Mar 28, 2028
US 10570453 ↗ Method of use U-4563 Mar 28, 2028
US 10570453 ↗ Method of use U-4562 Mar 28, 2028
US 10570453 ↗ Method of use U-4563 Mar 28, 2028
US 10570453 ↗ Method of use U-4562 Mar 28, 2028
US 10570453 ↗ Method of use U-4563 Mar 28, 2028
US 10570453 ↗ Method of use U-4562 Mar 28, 2028
US 10570453 ↗ Method of use U-4563 Mar 28, 2028
US 10570453 ↗ Method of use U-4562 Mar 28, 2028
US 10570453 ↗ Method of use U-4563 Mar 28, 2028
US 10570453 ↗ Method of use U-4562 Mar 28, 2028
US 10570453 ↗ Method of use U-4563 Mar 28, 2028
US 10563259 ↗ Method of use U-4562 Jul 24, 2030
US 10563259 ↗ Method of use U-4563 Jul 24, 2030
US 10563259 ↗ Method of use U-4562 Jul 24, 2030
US 10563259 ↗ Method of use U-4563 Jul 24, 2030
US 10563259 ↗ Method of use U-4562 Jul 24, 2030
US 10563259 ↗ Method of use U-4563 Jul 24, 2030
US 10563259 ↗ Method of use U-4562 Jul 24, 2030
US 10563259 ↗ Method of use U-4563 Jul 24, 2030
US 10563259 ↗ Method of use U-4562 Jul 24, 2030
US 10563259 ↗ Method of use U-4563 Jul 24, 2030
US 10563259 ↗ Method of use U-4562 Jul 24, 2030
US 10563259 ↗ Method of use U-4563 Jul 24, 2030
US 10563259 ↗ Method of use U-4562 Jul 24, 2030
US 10563259 ↗ Method of use U-4563 Jul 24, 2030
FDA exclusivity
CodeWhat it grantsExpires
I-939New indication (3-year)Apr 2, 2027
I-939New indication (3-year)Apr 2, 2027
I-939New indication (3-year)Apr 2, 2027
I-939New indication (3-year)Apr 2, 2027
I-939New indication (3-year)Apr 2, 2027
I-939New indication (3-year)Apr 2, 2027
I-939New indication (3-year)Apr 2, 2027
Common questions
Is there a generic version of FANAPT TITRATION PACK A?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for FANAPT TITRATION PACK A. See the alternatives section for substitutable, lower-cost products.
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 43068-0113-04, 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 – Q1 2026 · 5 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
120
Units reimbursed last 4 qtrs
108
Gross reimbursed last 4 qtrs
$27.8K
Avg / prescription
$231.83
Avg / unit
$257.59
Latest quarter Q1 2026
24Rx
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 39 Rx Managed care · 81 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 50 units · 0.4 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 27 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 12 units · 0.2 per 100k residents MO Kentucky: 19 units · 0.4 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.4
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 Ohio 0.4 /100k
2 Kentucky 0.4 /100k
3 Missouri 0.2 /100k
4 California 0.1 /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 Fanapt — 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 Fanapt. 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
$26.16M
Claims incl. refills
13.1K
Beneficiaries
4.3K
Spend / beneficiary
$6,061.08
Spend / claim
$1,994.18
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43068-0113-04 You're viewing this 1 BLISTER PACK in 1 DOSE PACK (43068-113-04) / 1 KIT in 1 BLISTER PACK 2015-12-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“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 43068-113-04, 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: 43068-0113-04, written without dashes as 43068011304. 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 43068-0113-04, the first segment (43068) is the labeler code FDA assigned to Vanda Pharmaceuticals Inc.; the middle segment (0113) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Vanda Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Vanda Pharmaceuticals 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.
🚨 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
🚨 Boxed Warning 91 words ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for use in patients with dementia-related psychosis. ( 5.1 )

🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE FANAPT ® is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ] . FANAPT is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1 , 14.2 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer FANAPT orally twice daily without regard to meals. ( 2.1 ) Titrate the dosage of FANAPT to avoid orthostatic hypotension. See Full Prescribing Information for titration schedule.

( 2.1 ) Recommended Dosage: Indication Starting Dosage Recommended Dosage Schizophrenia ( 2.1 ) 1 mg twice daily 6 mg to 12 mg twice daily Bipolar Mania ( 2.1 ) 1 mg twice daily 12 mg twice daily CYP2D6 Poor Metabolizers: See Full Prescribing Information for titration schedule and recommended dosage. ( 2.2 )

2.1Recommended Dosage Titrate FANAPT to avoid orthostatic hypotension [see Warnings and Precautions (5.7) ] . Administer FANAPT orally with or without food. Table 1 includes dosage recommendations for FANAPT for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Table 1: Dosage Recommendations for FANAPT in Adults for the Treatment of Schizophrenia or Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder Indication and Population Titration schedule Recommended Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Schizophrenia Titration Pack A 1mg twice daily 2 mg twice daily 4 mg twice daily 6 mg twice daily 8 mg twice daily 10 mg twice daily 12 mg twice daily 6 mg to 12 mg twice daily Bipolar I Disorder Manic or Mixed Episodes Titration Pack B 1 mg twice daily 3 mg twice daily 6 mg twice daily 9 mg twice daily 12 mg twice daily Titration complete 12 mg twice daily

2.2Dosage Recommendations for Use in Patients Who Are Known CYP2D6 Poor Metabolizers Reduce the dose of FANAPT by one-half for CYP2D6 poor metabolizers [see Clinical Pharmacology (12.3 , 12.5 )] . Table 2 includes dosage recommendations for FANAPT in adults who are CYP2D6 poor metabolizers. Table 2: Dosage Recommendations for FANAPT in Adults with Schizophrenia or Bipolar I Disorder Who are CYP2D6 Poor Metabolizers Indication and Population Titration schedule Recommended Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Schizophrenia Titration Pack A 1mg twice daily 2 mg twice daily 4 mg twice daily 6 mg twice daily Titration complete 3 mg to 6 mg twice daily Bipolar I Disorder Manic or Mixed Episodes Titration Pack C 1 mg twice daily 3 mg twice daily 6 mg twice daily Titration complete 6 mg twice daily

2.3Dosage Recommendations in Patients with Hepatic Impairment No dose adjustment for FANAPT is needed in patients with mild hepatic impairment. Patients with moderate hepatic impairment may require dose reduction, if clinically indicated. FANAPT is not recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.6) ] .

2.4Dosage Modifications for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inhibitors Coadministration with Strong CYP2D6 Inhibitors Reduce the dose of FANAPT one-half when administered concomitantly with strong CYP2D6 inhibitors such as fluoxetine or paroxetine. When the CYP2D6 inhibitor is withdrawn from the combination therapy, increase the dose of FANAPT to where it was before [see Drug Interactions (7.1) ] . Coadministration with Strong CYP3A4 Inhibitors Reduce the dose of FANAPT by one-half when administered concomitantly with strong CYP3A4 inhibitors such as ketoconazole or clarithromycin.

When the CYP3A4 inhibitor is withdrawn from the combination therapy, increase the dose of FANAPT to where it was before [see Drug Interactions (7.1) ] . Coadministration with Strong CYP2D6 and Strong CYP3A4 Inhibitors Reduce the dose of FANAPT by about one-half if administered concomitantly with inhibitors of CYP2D6 and CYP3A4. When both CYP2D6 and CYP3A4 inhibitors are withdrawn from the combination therapy, increase the dose of FANAPT to where it was before [see Drug Interactions (7.1) ] .

2.5Reinitiation of Treatment in Patients Previously Discontinued Although there are no data to specifically address reinitiation of treatment, it is recommended that the initiation titration schedule be follo…

💊 Dosage Forms and Strengths 83 words ▾

3 DOSAGE FORMS AND STRENGTHS FANAPT tablets are available in the following strengths: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. The tablets are white, round, flat, beveled-edged and identified with a logo “ ” debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side. 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets. ( 3 ) Tablet Imprint

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS FANAPT is contraindicated in individuals with a known hypersensitivity reaction to the product. Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported [see Adverse Reactions (6.2) ] . Known hypersensitivity to FANAPT or to any components in the formulation. ( 4 , 6.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia- Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). ( 5.2 ) QT prolongation: Prolongs QT interval and may be associated with arrhythmia and sudden death. Avoid use of FANAPT in combination with other drugs that are known to prolong QTc; use caution and consider dose modification when prescribing FANAPT with other drugs that inhibit FANAPT metabolism.

Monitor serum potassium and magnesium in patients at risk for electrolyte disturbances. ( 1 , 5.3 , 7.1 , 7.2 , 12.3 ) Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation of drug and close monitoring. ( 5.4 ) Tardive dyskinesia: Discontinue if clinically appropriate.

( 5.5 ) Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain. ( 5.6 ) Orthostatic hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. ( 5.7 ) Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

( 5.9 ) Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics. Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia. Consider discontinuing FANAPT if clinically significant decline in WBC occurs in the absence of other causative factors.

( 5.10 ) Priapism: Cases have been reported in association with FANAPT treatment. Severe priapism may require surgical intervention. ( 5.14 ) Potential for cognitive and motor impairment: Use caution when operating machinery.

( 5.15 ) Intraoperative Floppy Iris Syndrome (IFIS): IFIS during cataract surgery may require modifications to the surgical technique. ( 5.16 )

5.1Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 dementia-related psychosis placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo-treated patients.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning , Warnings and Precautions (5.2) ] .

5.2Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning , Warnings and Precautions (5.1) ] .

5.3QT Prolongation In an open-label QTc study in patients with schizophrenia or schizoaffective disorder (n=160), FANAPT was associated with QTc prolongation of 9 msec at an iloperidone dose of 12 mg twice daily. The effect of FANAPT on the QT interval was augmented by the presence of CYP450 2D6 or 3A4 metabolic inhibition (paroxetine 20 mg once daily and ketoconazole 200 mg twice daily, respectively). Under conditions of metabolic inhibition for both 2D6 and 3A4, FANAPT 12 mg twice daily was associated with a mean QTcF increase from baseline of about 19 msec.

No cases of torsade de pointes or other severe cardiac arrhythm…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.1) ] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2) ] QT Prolongation [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.7) ] Falls [see Warnings and Precautions (5.8) ] Seizures [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia and Agranulocytosis [see Warnings and Precautions (5.10) ] Hyperprolactinemia [see Warnings and Precautions (5.11) ] Body Temperature Regulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Priapism [see Warnings and Precautions (5.14) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.15) ] Intraoperative Floppy Iris Syndrome [see Warnings and Precautions (5.16) ] Commonly observed adverse reactions (incidence ≥5% and 2-fold greater than placebo) were ( 6.1 ): Schizophrenia: dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.

Bipolar mania: tachycardia, dizziness, dry mouth, hepatic enzymes increased, nasal congestion, weight increased, hypotension, and somnolence. To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The information below is derived from a clinical trial database for FANAPT consisting of 3,229 patients exposed to FANAPT at doses of 10 mg/day or greater, for the treatment of schizophrenia and from a clinical trial database for FANAPT consisting of 312 patients exposed to FANAPT at doses of 24 mg/day, for the treatment of bipolar mania [see Clinical Studies (14.2) ] .

Of these, 999 received FANAPT for at least 6 months, with 657 exposed to FANAPT for at least 12 months for the treatment of schizophrenia and 69 received FANAPT for at least 6 months, with 28 exposed to FANAPT for at least 12 months for the treatment of bipolar mania. All of these patients who received FANAPT were participating in multiple-dose clinical trials. The conditions and duration of treatment with FANAPT varied greatly and included (in overlapping categories), open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and flexible-dose studies, and short-term and longer-term exposure.

Schizophrenia The information presented in this section was derived from pooled data from 4 placebo-controlled, 4- or 6-week, fixed- or flexible-dose studies in patients who received FANAPT at daily doses within a range of 10 to 24 mg (n=874). Adverse Reactions Occurring at an Incidence of 2% or More among FANAPT-Treated Patients and More Frequent than Placebo Table 3 enumerates the pooled incidences of adverse reactions that were spontaneously reported in four placebo-controlled, 4- or 6-week, fixed- or flexible-dose studies, listing those reactions that occurred in 2% or more of patients treated with FANAPT in any of the dose groups, and for which the incidence in FANAPT- treated patients in any dose group was greater than the incidence in patients treated with placebo.

Table 3: Percentage of Adverse Reactions in Short-Term, Fixed- or Flexible-Dose, Placebo- Controlled Schizophrenia Trials in Adult Patie…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS The dose of FANAPT should be reduced in patients co-administered a strong CYP2D6 or CYP3A4 inhibitor. ( 2.2 , 7.1 )

7.1Clinically Important Drug Interactions with FANAPT Table 7 presents clinically important drug interactions with FANAPT. Table 7: Clinically Important Drug Interactions with FANAPT Strong CYP2D6 Inhibitors Clinical Impact Coadministration of fluoxetine with iloperidone increased exposure (area under curve, [AUC]) of iloperidone and its metabolite P88, by about 2- to 3- fold, and decreased the AUC of its metabolite P95 by one-half [see Clinical Pharmacology (12.3 , 12.5) ] . Coadministration of paroxetine with iloperidone resulted in increased mean steady-state peak concentrations of iloperidone and its metabolite P88, by about 1.6- fold, and decreased mean steady-state peak concentrations of its metabolite P95 by one-half [see Clinical Pharmacology (12.3 , 12.5) ] .

Intervention Reduce the dose of FANAPT by one-half when administered with strong CYP2D6 inhibitors. When a strong CYP2D6 inhibitor is withdrawn from the combination therapy, the iloperidone dose should be returned to the previous level [see Dosage and Administration (2.4) ] . Strong CYP3A4 Inhibitors Clinical Impact Co-administration of ketoconazole with iloperidone, increased the AUC of iloperidone and its metabolites P88 and P95 by 57%, 55%, and 35%, respectively [see Clinical Pharmacology (12.3) ] .

Intervention Reduce the dose of FANAPT by one-half when administered with strong CYP3A4 inhibitors. When the CYP3A4 inhibitor is withdrawn from the combination therapy, the FANAPT dose should be returned to the previous level [see Dosage and Administration (2.4) ] . Concomitant use of Strong CYP2D6 and Strong CYP3A4 Inhibitors Clinical Impact Coadministration of iloperidone with paroxetine and ketoconazole resulted in a 1.4- fold increase in steady-state concentrations of iloperidone and its metabolite P88 and a 1.4- fold decrease in the P95 in the presence of paroxetine [see Clinical Pharmacology (12.3) ] .

Intervention Coadministration of FANAPT with inhibitors of both CYP2D6 and CYP3A4 did not add to the effect of either inhibitor given alone. Reduce the dose of FANAPT by about one-half if administered concomitantly with both a CYP2D6 and CYP3A4 inhibitor same as if it is coadministered with only one inhibitor. When the inhibitors of CYP2D6 and CYP3A4 are withdrawn from the combination therapy, the FANAPT dose should be returned to the previous level [see Dosage and Administration (2.4) ] .

7.2Drugs that Prolong the QT Interval Concomitant use of drugs that prolong the QT interval may add to the QT effects of FANAPT and increase the risk of cardiac arrhythmia. Avoid the use of FANAPT in combination with any other drugs that prolong the QT interval [see Warnings and Precautions (5.3) ] .

7.3Drugs that Lower Blood Pressure Concomitant use of FANAPT with medications that lower blood pressure could potentially cause symptomatic hypotension. Avoid coadministration of FANAPT with alpha-adrenergic blocking agents and adjust medications that affect blood pressure as needed [see Warnings and Precautions (5.7) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. ( 8.1 ) Lactation: Advise not to breast feed. ( 8.2 ) Pediatric Use: Safety and effectiveness not established in children and adolescents. ( 8.4 ) Hepatic Impairment: FANAPT is not recommended for patients with severe hepatic impairment. ( 2.3 , 8.6 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FANAPT during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Neonates whose mothers are exposed to antipsychotic drugs, including FANAPT, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see Clinical Considerations ] .

The limited available data with FANAPT in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Iloperidone was not teratogenic when administered orally to pregnant rats during organogenesis at doses up to 26 times the maximum recommended human dose of 24 mg/day on mg/m 2 basis. However, it prolonged the duration of pregnancy and parturition, increased still births, early intrauterine deaths, increased incidence of developmental delays, and decreased post-partum pup survival.

Iloperidone was not teratogenic when administered orally to pregnant rabbits during organogenesis at doses up to 20-times the MRHD on mg/m 2 basis. However, it increased early intrauterine deaths and decreased fetal viability at term at the highest dose which was also a maternally toxic dose [see Data] . The 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. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates whose mothers were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity.

Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Data Animal Data In an embryo-fetal development study, pregnant rats were given 4, 16, or 64 mg/kg/day (1.6, 6.5, and 26 times the maximum recommended human dose (MRHD) of 24 mg/day on a mg/m 2 basis) of iloperidone orally during the period of organogenesis.

The highest dose caused increased early intrauterine deaths, decreased fetal weight and length, decreased fetal skeletal ossification, and an increased incidence of minor fetal skeletal anomalies and variations; this dose also caused decreased maternal food consumption and weight gain. In an embryo-fetal development study, pregnant rabbits were given 4, 10, or 25 mg/kg/day (3, 8, and 20 times the MRHD on a mg/m 2 basis) of iloperidone during the period of organogenesis. The highest dose caused increased early intrauterine deaths and decreased fetal viability at term; this dose also caused maternal toxicity.

In additional studies in which rats were given iloperidone at doses similar to the above beginning from either pre-conception or from day 17 of gestation and continuing through weaning, adverse reproductive effects included prolonged pregnancy and parturition, increased stillbirth rates, increased incidence of fetal visceral variations, decreased fetal and pup weights, and decreased post-partum pup survival. There were no drug effects o…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FANAPT during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Neonates whose mothers are exposed to antipsychotic drugs, including FANAPT, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see Clinical Considerations ] .

The limited available data with FANAPT in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Iloperidone was not teratogenic when administered orally to pregnant rats during organogenesis at doses up to 26 times the maximum recommended human dose of 24 mg/day on mg/m 2 basis. However, it prolonged the duration of pregnancy and parturition, increased still births, early intrauterine deaths, increased incidence of developmental delays, and decreased post-partum pup survival.

Iloperidone was not teratogenic when administered orally to pregnant rabbits during organogenesis at doses up to 20-times the MRHD on mg/m 2 basis. However, it increased early intrauterine deaths and decreased fetal viability at term at the highest dose which was also a maternally toxic dose [see Data] . The 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. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates whose mothers were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity.

Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Data Animal Data In an embryo-fetal development study, pregnant rats were given 4, 16, or 64 mg/kg/day (1.6, 6.5, and 26 times the maximum recommended human dose (MRHD) of 24 mg/day on a mg/m 2 basis) of iloperidone orally during the period of organogenesis.

The highest dose caused increased early intrauterine deaths, decreased fetal weight and length, decreased fetal skeletal ossification, and an increased incidence of minor fetal skeletal anomalies and variations; this dose also caused decreased maternal food consumption and weight gain. In an embryo-fetal development study, pregnant rabbits were given 4, 10, or 25 mg/kg/day (3, 8, and 20 times the MRHD on a mg/m 2 basis) of iloperidone during the period of organogenesis. The highest dose caused increased early intrauterine deaths and decreased fetal viability at term; this dose also caused maternal toxicity.

In additional studies in which rats were given iloperidone at doses similar to the above beginning from either pre-conception or from day 17 of gestation and continuing through weaning, adverse reproductive effects included prolonged pregnancy and parturition, increased stillbirth rates, increased incidence of fetal visceral variations, decreased fetal and pup weights, and decreased post-partum pup survival. There were no drug effects on the neurobehavioral or reproductive development of the surviving pups. No-effect doses ranged from 4 to 12 mg/kg except for the increase in stillbirth rates which occurred at the lowest dose tested of 4 mg/kg, which is 1.6 times the MRHD on a mg/m 2 basis.

Maternal toxicity was seen at the higher doses in these studies. The iloperidone metabolite P95, which is a major circulating met…

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of FANAPT have not been established in pediatric patients.

🧓 Geriatric Use 133 words ▾

8.5Geriatric Use Clinical Studies of FANAPT in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 years and over to determine whether or not they respond differently than younger adult patients. Of the 3,210 patients with schizophrenia treated with FANAPT in clinical trials, 25 (0.5%) were ≥65 years old and there were no patients ≥75 years old. Of the 206 patients with bipolar mania treated with FANAPT in a clinical trial, 2 (0.1%) were 65 years old and there were no patients were >65 years old.

Elderly patients with dementia-related psychosis treated with FANAPT are at an increased risk of death compared to placebo. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1 , 5.2) ] .

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Human Experience In pre-marketing trials involving over 3,522 patients, accidental or intentional overdose of FANAPT was documented in 8 patients ranging from 48 mg to 576 mg taken at once and 292 mg taken over a 3-day period. No fatalities were reported from these cases. The largest confirmed single ingestion of FANAPT was 576 mg; no adverse physical effects were noted for this patient.

The next largest confirmed ingestion of FANAPT was 438 mg over a 4-day period; extrapyramidal symptoms and a QTc interval of 507 msec were reported for this patient with no cardiac sequelae. This patient resumed FANAPT treatment for an additional 11 months. In general, reported signs and symptoms were those resulting from an exaggeration of the known pharmacological effects (e.g., drowsiness and sedation, tachycardia and hypotension) of FANAPT.

10.2Management of Overdose There is no specific antidote for FANAPT. Therefore appropriate supportive measures should be instituted. In case of acute overdose, the healthcare provider should establish and maintain an airway and ensure adequate oxygenation and ventilation.

Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizures or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous ECG monitoring to detect possible arrhythmias.

If antiarrhythmic therapy is administered, disopyramide, procainamide and quinidine should not be used, as they have the potential for QT-prolonging effects that might be additive to those of FANAPT. Similarly, it is reasonable to expect that the alpha-blocking properties of bretylium might be additive to those of FANAPT, resulting in problematic hypotension. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of FANAPT-induced alpha blockade).

In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision should continue until the patient recovers. Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. Iloperidone forms an active metabolite, P88, that has an in vitro receptor binding profile similar to the parent drug.

12.2Pharmacodynamics Iloperidone acts as an antagonist with high (nM) affinity binding to serotonin 5-HT 2A, dopamine D 2 and D 3 receptors, and norepinephrine NEα1 receptors (K i values of 5.6, 6.3, 7.1, and 0.36 nM, respectively). Iloperidone has moderate affinity for dopamine D 4 , and serotonin 5-HT 6 and 5-HT 7 receptors (K i values of 25, 43, and 22, nM respectively), and low affinity for the serotonin 5-HT 1A , dopamine D 1 , and histamine H 1 receptors (K i values of 168, 216, and 437 nM, respectively). Iloperidone has no appreciable affinity (K i >1000 nM) for cholinergic muscarinic receptors.

The affinity of iloperidone metabolite P88 is generally equal to or less than that of the parent compound, while the metabolite P95 only shows affinity for 5-HT 2A (K i value of 3.91) and the NE α1A , NE α1B , NE α1D , and NE α2 C receptors (K i values of 4.7, 2.7, 8.8, and 4.7 nM respectively).

12.3Pharmacokinetics The pharmacokinetics of iloperidone is more than dose proportional. Steady-state concentrations are attained within 3 to 4 days of dosing. Iloperidone accumulation is predictable from single-dose pharmacokinetics.

Absorption Iloperidone is well absorbed after administration of the tablet with time to peak plasma concentrations (T max ) occurring within 2 to 4 hours. The relative bioavailability of the tablet formulation compared to oral solution is 96%. Effect of Food Administration of iloperidone with a standard high-fat meal did not significantly affect the C max or AUC of iloperidone, P88, or P95, but delayed T max by 1 hour for iloperidone, 2 hours for P88 and 6 hours for P95.

FANAPT can be administered without regard to meals. Distribution Iloperidone has an apparent volume of distribution of 1340-2800 L. At therapeutic concentrations, the unbound fraction of iloperidone in plasma is ~3% and of each metabolite (P88 and P95) it is ~8%.

Elimination The observed mean elimination half-lives for iloperidone, P88, and P95 in CYP2D6 extensive metabolizers (EM) are 18, 26, and 23 hours, respectively, and in poor metabolizers (PM) are 33, 37, and 31 hours, respectively. Iloperidone has an apparent clearance (clearance / bioavailability) of 47 to 102 L/h. Metabolism Elimination of iloperidone is mainly through hepatic metabolism.

Iloperidone is metabolized primarily by 3 biotransformation pathways: carbonyl reduction, hydroxylation (mediated by CYP2D6) and O-demethylation (mediated by CYP3A4). There are 2 predominant iloperidone metabolites, P95 and P88. The iloperidone metabolite P95 represents 47.9% of the AUC of iloperidone and its metabolites in plasma at steady-state for extensive metabolizers (EM) and 25% for poor metabolizers (PM).

The active metabolite P88 accounts for 19.5% and 34.0% of total plasma exposure in EM and PM, respectively. Approximately 7% - 10% of Caucasians and 3% - 8% of black/African Americans lack the capacity to metabolize CYP2D6 substrates and are classified as poor metabolizers (PM), whereas the rest are intermediate, extensive, or ultrarapid metabolizers. Excretion The bulk of the radioactive materials were recovered in the urine (mean 58.2% and 45.1% in EM and PM, respectively), with feces accounting for 19.9% (EM) to 22.1% (PM) of the dosed radioactivity.

Specific Populations Patients with Renal Impairment Renal impairment (creatinine clearance <30 mL/min) had minimal effect on C max of iloperidone (given in a single dose of 3 mg) and its metabolites P88 and P95 in any of the 3 analytes measured. AUC 0–∞ was increased by 24%, decreased by 6%, and increased by 52% for iloperidone, P88 and P…

🧬 Mechanism of Action 63 words ▾

12.1Mechanism of Action The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. Iloperidone forms an active metabolite, P88, that has an in vitro receptor binding profile similar to the parent drug.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING FANAPT tablets are white, round and identified with a logo “ ” debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side. Tablets are supplied in the following strengths and package configurations: Package Configuration Tablet Strength (mg) NDC Code Bottles of 60 1 mg 43068-101-02 Bottles of 60 2 mg 43068-102-02 Bottles of 60 4 mg 43068-104-02 Bottles of 60 6 mg 43068-106-02 Bottles of 60 8 mg 43068-108-02 Bottles of 60 10 mg 43068-110-02 Bottles of 60 12 mg 43068-112-02 Package Configuration Indication Tablet Quantity and Strength (mg) NDC Code Titration Pack A For the treatment of schizophrenia Two 1 mg tablets Two 2 mg tablets Two 4 mg tablets Two 6 mg tablets (Total of 8 tablets) 43068-113-04 Titration Pack B For the acute treatment of manic or mixed episodes associated with bipolar I disorder Six 1 mg tablets Two 2 mg tablets Two 6 mg tablets Two 8 mg tablets (Total of 12 tablets) 43068-115-04 Titration Pack C For the acute treatment of manic or mixed episodes associated with bipolar I disorder in patients who are known CYP2D6 poor metabolizers Four 1 mg tablets Two 2 mg tablets Two 6 mg tablets (Total of 8 tablets) 43068-114-03 Storage Store FANAPT tablets at controlled room temperature, 25℃ (77℉); excursions permitted to 15° to 30 ℃ (59° to 86℉) [See USP Controlled Room Temperature].

Protect FANAPT tablets from exposure to light and moisture.

📋 Description 160 words ▾

11 DESCRIPTION FANAPT is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4’-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3’-methoxyacetophenone. Its molecular formula is C 24 H 27 FN 2 O 4 and its molecular weight is 426.48.

The structural formula is: Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in

0.1N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. FANAPT tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone.

Inactive ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and purified water (removed during processing). The tablets are white, round, flat, beveled-edged, and identified with a logo “ ” debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side. FANAPT structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION QT Interval Prolongation Patients should be advised to consult their healthcare provider immediately if they feel faint, lose consciousness or have heart palpitations. Patients should be counseled not to take FANAPT with other drugs that cause QT interval prolongation [see Warnings and Precautions (5.3) ] . Patients should be told to inform their healthcare provider that they are taking FANAPT before any new drug is taken.

Neuroleptic Malignant Syndrome (NMS) Counsel patients and caregivers about a potentially fatal adverse reaction, NMS, that has been reported with administration of antipsychotic drugs, including FANAPT. Advise patients and caregivers to contact the healthcare provider or to report to the emergency room if they experience signs and symptoms of NMS [see Warnings and Precautions (5.4) ] . Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions (5.5) ] .

Metabolic Changes Educate patients of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight. Patients should be counseled that weight gain has occurred during treatment with FANAPT [see Warnings and Precautions (5.6) ] . Orthostatic Hypotension and Syncope Educate patients about the risk of orthostatic hypotension and syncope, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions (5.7) ] .

Leukopenia/Neutropenia Advise patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia that they should have their CBC monitored while taking FANAPT [see Warnings and Precautions (5.10) ] . Heat Exposure and Dehydration Educate patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.12) ] . Interference with Cognitive and Motor Performance Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that FANAPT therapy does not affect them adversely [see ( Warnings and Precautions (5.15) ] .

Intraoperative Floppy Iris Syndrome Instruct patients to tell their ophthalmologist about their use of FANAPT before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking FANAPT [see Warnings and Precautions (5.16) ] . Pregnancy Advise patients that third trimester use of FANAPT may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to notify their healthcare provider with known or suspected pregnancy [see Use in Specific Populations (8.1) ] .

Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FANAPT during pregnancy [see Use in Specific Populations (8.1) ] . Lactation Advise women not to breastfeed during treatment with FANAPT [see Use in Specific Populations (8.2) ] . Concomitant Medication Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7) ] .

Alcohol Patients should be advised to avoid alcohol while taking FANAPT. Distributed by: Vanda Pharmaceuticals Inc. Washington, D.C.

20037 USA Vanda and Fanapt ® are registered trademarks of Vanda Pharmaceuticals Inc. in the United States and other countries.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43068-0112-02 · Vanda 43068-0114-03 · Vanda →
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.