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CAPLYTA lumateperone 21 mg Capsule, 30-count — NDC 72060-0121-40 package photo

CAPLYTA lumateperone 21 mg Capsule, 30-count

by Intra-Cellular Therapies, Inc · 30 CAPSULE in 1 BOTTLE (72060-121-40)
NDC 72060-0121-40
🏷️ FDA NDC (as labeled) 72060-121-40 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$57.23 NADAC Per package$1,716.87 / 30 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $54.75/unit · Part D plans $57.46/unit — full pricing hub ↓
Also comes in: 7 capsules 72060-0121-07
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) 72060-121-40
Product NDC 72060-121
11-digit billing NDC 72060012140
NCPDP billing unit EA — each (per item)
RxCUI 2275607, 2275613, 2607529, 2607531, 2607533, 2607535
UNII 70BSQ12069
UPC 0372060110402, 0372060121408
Application # NDA209500
SPL Set ID db730b06-6351-47fd-8183-e61e61bbead5
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-09
Route ORAL
Dosage form CAPSULE
Substance LUMATEPERONE
GPI-14 59400022400115
GCN Seq No 083619
GCN 52617
HICL code 046280
Ingredient (HICL) Lumateperone Tosylate
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 CAPLYTA 21 MG CAPSULE
FDB brand name Caplyta
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 72060-121-40 — 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 → 72060-0121-40. 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) Butyrophenone derivatives
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

LabelerIntra-Cellular Therapies, Inc
Application holderINTRA-CELLULAR THERAPIES INC
FDA applicationNDA209500 (NDA)
Labeler code72060
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio3 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 CAPLYTA 21 MG CAPSULE Ingredient Lumateperone Tosylate
📖 What it is MedlinePlus · NLM

Lumateperone is used to treat: schizophrenia (a mental illness that affects how a person thinks, feels and behaves) bipolar I disorder (a disease that causes depression, mania, and other abnormal moods) major depressive disorderLumateperone 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
  • You're right on both counts — lumateperone (Caplyta) is classified as an atypical antipsychotic, but it's approved for more than just schizophrenia. It's also approved to treat the...
  • What exactly is Caplyta used for? My doctor prescribed it for depression, but I thought it was an antipsychotic.
  • Drowsiness and sedation are among the most common side effects, especially early on. Many people find this improves over time as their body adjusts. It's worth giving it a few week...
  • Will Caplyta make me really drowsy? I can't afford to be foggy at work.
📖 Read our full Lumateperone 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 Blue / White / white / pink
ShapeCapsule
ImprintITI;007;10;5;mg
Size18 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive 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 eaPer package
Retail pharmacies payNADAC · weekly $57.229 $1,716.87 / 30 capsules
Medicaid paysCMS SDUD · 12 mo $54.75 $1,642.56 / 30 capsules
Medicare drug plans payPart D · Q2 2026 $57.46 $1,723.80 / 30 capsules
NADAC price history (per ea) — tap or hover for the price & month
Nov 2022 Dec 2025 May 2026 Aug 2026 $57.353 $47.424
▲ Up 21% over the last 8 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Caplyta 21 mgthis 72060-0121-40 Intra-Cellular 30 capsules $57.229 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
First FDA approval
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2040
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 Dec 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 20, 2019 RLD RS ⏳ ~14.2 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 9956227 — method of use (U-2714)
US 9199995 — method of use (U-2713)
US 8598119 — method of use (U-543)
US 12122792 — method of use (U-4019)
US 12122792 — method of use (U-4019)
US 12122792 — method of use (U-4019)
US 12122792 — method of use (U-4020)
US 12122792 — method of use (U-4020)
US 12122792 — method of use (U-4020)
US 12090155 — method of use (U-4000)
US 10695345 — method of use (U-543)
US 12128043 — method of use (U-3362)
US 12128043 — method of use (U-3363)
US 11806348 — method of use (U-3362)
US 11806348 — method of use (U-3363)
US 11806348 — method of use (U-3363)
US 11806348 — method of use (U-3363)
US 11806348 — method of use (U-3362)
US 11806348 — method of use (U-3362)
US 12070459 — method of use (U-3362)
US 12070459 — method of use (U-3363)
US 12122792 — method of use (U-4340)
US 12122792 — method of use (U-4340)
US 12122792 — method of use (U-4340)
US 12070459 — method of use (U-4341)
US 11980617 — method of use (U-4342)
US 11980617 — method of use (U-4342)
US 12409176 — method of use (U-4261)
US 12409176 — method of use (U-4261)
US 9199995 — method of use (U-4343)
US 9199995 — method of use (U-4343)
US 9199995 — method of use (U-4343)
US 11980617 — method of use (U-4342)
US 11806348 — method of use (U-4341)
US 11806348 — method of use (U-4341)
US 11806348 — method of use (U-4341)
US 11690842 — method of use (U-4341)
US 11690842 — method of use (U-4341)
US 11690842 — method of use (U-4341)
US 11052084 — method of use (U-4341)
US 11052084 — method of use (U-4341)
US RE48839 — method of use (U-4344)
US RE48839 — method of use (U-4344)
US RE48839 — method of use (U-4344)
US 12409176 — method of use (U-4261)
US 11980617 — method of use (U-3940)
US 11980617 — method of use (U-3940)
US 11980617 — method of use (U-3940)
US RE48839 — method of use (U-3271)
US 10960009 — method of use (U-814)
US RE48839 — method of use (U-814)
US 10117867 — method of use (U-3271)
US 11026951 — method of use (U-3274)
US 11690842 — method of use (U-3362)
US 11690842 — method of use (U-3362)
US 11690842 — method of use (U-3362)
US 11690842 — method of use (U-3363)
US 11690842 — method of use (U-3363)
US 11690842 — method of use (U-3363)
US 11052084 — method of use (U-3362)
US 11052084 — method of use (U-3363)
US 11052084 — method of use (U-3363)
US 11052084 — method of use (U-3362)
US 11026951 — method of use (U-3364)
US 11026951 — method of use (U-3364)
US 10695345 — method of use (U-814)
US 10695345 — method of use (U-814)
US 10117867 — method of use (U-3271)
US 10117867 — method of use (U-3271)
US 9956227 — method of use (U-2714)
US 9956227 — method of use (U-2714)
US 9199995 — method of use (U-2713)
US 9199995 — method of use (U-2713)
US RE48839 — method of use (U-3271)
US RE48839 — method of use (U-814)
US RE48839 — method of use (U-814)
US RE48839 — method of use (U-3271)
US 12410195 — drug product
US 8648077 — drug substance
US 9616061 — drug product
US 11753419 — drug product
US 9168258 — drug product
US 11753419 — drug product
US 12410195 — drug product
US RE48825 — drug substance
US 8648077 — drug substance
US 12410195 — drug product
US RE48825 — drug substance
US 11753419 — drug product
US 10464938 — drug product
US 9586960 — drug substance
US 8648077 — drug substance
US 9616061 — drug product
US RE48825 — drug substance
US 9616061 — drug product
US 10464938 — drug product
US 10464938 — drug product
Exclusivity I-904
Exclusivity M-319
Exclusivity I-904
Exclusivity M-319
Exclusivity I-904
Exclusivity M-319
2019 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 (97)
PatentTypeUse codeExpires
US 9956227 ↗ Method of use U-2714 Dec 3, 2034
US 9199995 ↗ Method of use U-2713 Mar 12, 2029
US 8598119 ↗ delist req. Method of use U-543 Dec 28, 2029
US 12122792 ↗ Method of use U-4019 Dec 10, 2040
US 12122792 ↗ Method of use U-4019 Dec 10, 2040
US 12122792 ↗ Method of use U-4019 Dec 10, 2040
US 12122792 ↗ Method of use U-4020 Dec 10, 2040
US 12122792 ↗ Method of use U-4020 Dec 10, 2040
US 12122792 ↗ Method of use U-4020 Dec 10, 2040
US 12090155 ↗ Method of use U-4000 Jul 7, 2040
US 10695345 ↗ Method of use U-543 Aug 30, 2039
US 12128043 ↗ Method of use U-3362 Aug 30, 2039
US 12128043 ↗ Method of use U-3363 Aug 30, 2039
US 11806348 ↗ Method of use U-3362 Aug 30, 2039
US 11806348 ↗ Method of use U-3363 Aug 30, 2039
US 11806348 ↗ Method of use U-3363 Aug 30, 2039
US 11806348 ↗ Method of use U-3363 Aug 30, 2039
US 11806348 ↗ Method of use U-3362 Aug 30, 2039
US 11806348 ↗ Method of use U-3362 Aug 30, 2039
US 12070459 ↗ Method of use U-3362 Aug 30, 2039
US 12070459 ↗ Method of use U-3363 Aug 30, 2039
US 12122792 ↗ Method of use U-4340 Dec 10, 2040
US 12122792 ↗ Method of use U-4340 Dec 10, 2040
US 12122792 ↗ Method of use U-4340 Dec 10, 2040
US 12070459 ↗ Method of use U-4341 Aug 30, 2039
US 11980617 ↗ Method of use U-4342 Oct 27, 2039
US 11980617 ↗ Method of use U-4342 Oct 27, 2039
US 12409176 ↗ Method of use U-4261 Mar 15, 2039
US 12409176 ↗ Method of use U-4261 Mar 15, 2039
US 9199995 ↗ Method of use U-4343 Mar 12, 2029
US 9199995 ↗ Method of use U-4343 Mar 12, 2029
US 9199995 ↗ Method of use U-4343 Mar 12, 2029
US 11980617 ↗ Method of use U-4342 Oct 27, 2039
US 11806348 ↗ Method of use U-4341 Aug 30, 2039
US 11806348 ↗ Method of use U-4341 Aug 30, 2039
US 11806348 ↗ Method of use U-4341 Aug 30, 2039
US 11690842 ↗ Method of use U-4341 Aug 30, 2039
US 11690842 ↗ Method of use U-4341 Aug 30, 2039
US 11690842 ↗ Method of use U-4341 Aug 30, 2039
US 11052084 ↗ Method of use U-4341 Aug 30, 2039
US 11052084 ↗ Method of use U-4341 Aug 30, 2039
US RE48839 ↗ Method of use U-4344 Aug 19, 2033
US RE48839 ↗ Method of use U-4344 Aug 19, 2033
US RE48839 ↗ Method of use U-4344 Aug 19, 2033
US 12409176 ↗ Method of use U-4261 Mar 15, 2039
US 11980617 ↗ Method of use U-3940 Oct 27, 2039
US 11980617 ↗ Method of use U-3940 Oct 27, 2039
US 11980617 ↗ Method of use U-3940 Oct 27, 2039
US RE48839 ↗ Method of use U-3271 Aug 19, 2033
US 10960009 ↗ Method of use U-814 Dec 3, 2034
US RE48839 ↗ Method of use U-814 Aug 19, 2033
US 10117867 ↗ Method of use U-3271 May 27, 2029
US 11026951 ↗ Method of use U-3274 Dec 3, 2034
US 11690842 ↗ Method of use U-3362 Aug 30, 2039
US 11690842 ↗ Method of use U-3362 Aug 30, 2039
US 11690842 ↗ Method of use U-3362 Aug 30, 2039
US 11690842 ↗ Method of use U-3363 Aug 30, 2039
US 11690842 ↗ Method of use U-3363 Aug 30, 2039
US 11690842 ↗ Method of use U-3363 Aug 30, 2039
US 11052084 ↗ Method of use U-3362 Aug 30, 2039
US 11052084 ↗ Method of use U-3363 Aug 30, 2039
US 11052084 ↗ Method of use U-3363 Aug 30, 2039
US 11052084 ↗ Method of use U-3362 Aug 30, 2039
US 11026951 ↗ Method of use U-3364 Dec 3, 2034
US 11026951 ↗ Method of use U-3364 Dec 3, 2034
US 10695345 ↗ Method of use U-814 Aug 30, 2039
US 10695345 ↗ Method of use U-814 Aug 30, 2039
US 10117867 ↗ Method of use U-3271 May 27, 2029
US 10117867 ↗ Method of use U-3271 May 27, 2029
US 9956227 ↗ Method of use U-2714 Dec 3, 2034
US 9956227 ↗ Method of use U-2714 Dec 3, 2034
US 9199995 ↗ Method of use U-2713 Mar 12, 2029
US 9199995 ↗ Method of use U-2713 Mar 12, 2029
US RE48839 ↗ Method of use U-3271 Aug 19, 2033
US RE48839 ↗ Method of use U-814 Aug 19, 2033
US RE48839 ↗ Method of use U-814 Aug 19, 2033
US RE48839 ↗ Method of use U-3271 Aug 19, 2033
US 12410195 ↗ Drug product — Dec 10, 2040
US 8648077 ↗ Drug substance — Dec 1, 2029
US 9616061 ↗ Drug product — May 27, 2029
US 11753419 ↗ delist req. Drug product — Dec 10, 2040
US 9168258 ↗ Drug product — May 27, 2029
US 11753419 ↗ delist req. Drug product — Dec 10, 2040
US 12410195 ↗ Drug product — Dec 10, 2040
US RE48825 ↗ Drug substance — Mar 12, 2029
US 8648077 ↗ Drug substance — Dec 1, 2029
US 12410195 ↗ Drug product — Dec 10, 2040
US RE48825 ↗ Drug substance — Mar 12, 2029
US 11753419 ↗ delist req. Drug product — Dec 10, 2040
US 10464938 ↗ Drug product — Mar 12, 2028
US 9586960 ↗ Drug substance — Mar 12, 2029
US 8648077 ↗ Drug substance — Dec 1, 2029
US 9616061 ↗ Drug product — May 27, 2029
US RE48825 ↗ Drug substance — Mar 12, 2029
US 9616061 ↗ Drug product — May 27, 2029
US 10464938 ↗ Drug product — Mar 12, 2028
US 10464938 ↗ Drug product — Mar 12, 2028
FDA exclusivity
CodeWhat it grantsExpires
I-904New indication (3-year)Nov 5, 2028
M-319New indication / labeling change (3-year)Apr 24, 2029
I-904New indication (3-year)Nov 5, 2028
M-319New indication / labeling change (3-year)Apr 24, 2029
I-904New indication (3-year)Nov 5, 2028
M-319New indication / labeling change (3-year)Apr 24, 2029
Common questions
Is there a generic version of CAPLYTA 21 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CAPLYTA 21 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2040 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72060-0121-40, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
53.8K
Units reimbursed last 4 qtrs
1.6M
Gross reimbursed last 4 qtrs
$87.96M
Avg / prescription
$1,635.45
Avg / unit
$54.7521
Latest quarter Q4 2025
15.1KRx
Medicaid pays / ea
$54.7521
gross reimbursed
vs
NADAC / ea
$57.2291
acquisition cost
=
Spread
−$2.4770
-4% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
48% FFS 52% MCO
Fee-for-service · 25,901 Rx Managed care · 27,880 Rx
State Medicaid map
Alaska: 571 units · 77.9 per 100k residents AK Maine: 3,391 units · 243 per 100k residents ME Washington: 15,925 units · 204 per 100k residents WA Idaho: 18,472 units · 941 per 100k residents ID Montana: 2,968 units · 262 per 100k residents MT North Dakota: 941 units · 120 per 100k residents ND Minnesota: 11,725 units · 204 per 100k residents MN Wisconsin: 12,213 units · 207 per 100k residents WI Michigan: 119,142 units · 1,187 per 100k residents MI New York: 130,939 units · 669 per 100k residents NY Vermont: 1,242 units · 192 per 100k residents VT New Hampshire: 1,574 units · 112 per 100k residents NH Oregon: 22,281 units · 526 per 100k residents OR Nevada: 20,311 units · 636 per 100k residents NV Wyoming: 416 units · 71.2 per 100k residents WY South Dakota: 4,634 units · 504 per 100k residents SD Iowa: 23,936 units · 746 per 100k residents IA Illinois: 32,849 units · 262 per 100k residents IL Indiana: 135,009 units · 1,967 per 100k residents IN Ohio: 175,013 units · 1,485 per 100k residents OH Pennsylvania: 31,478 units · 243 per 100k residents PA New Jersey: 15,391 units · 166 per 100k residents NJ Massachusetts: 11,341 units · 162 per 100k residents MA California: 167,823 units · 431 per 100k residents CA Utah: 16,160 units · 473 per 100k residents UT Colorado: 22,676 units · 386 per 100k residents CO Nebraska: 9,569 units · 484 per 100k residents NE Missouri: 32,110 units · 518 per 100k residents MO Kentucky: 87,488 units · 1,933 per 100k residents KY West Virginia: 1,113 units · 62.9 per 100k residents WV Virginia: 34,181 units · 392 per 100k residents VA Maryland: 5,261 units · 85.1 per 100k residents MD Connecticut: 104,686 units · 2,894 per 100k residents CT Rhode Island: 2,814 units · 257 per 100k residents RI Arizona: 10,856 units · 146 per 100k residents AZ New Mexico: 11,191 units · 529 per 100k residents NM Kansas: 8,017 units · 273 per 100k residents KS Arkansas: 1,432 units · 46.7 per 100k residents AR Tennessee: 51,883 units · 728 per 100k residents TN North Carolina: 60,323 units · 557 per 100k residents NC South Carolina: 4,770 units · 88.8 per 100k residents SC Delaware: 3,561 units · 345 per 100k residents DE Oklahoma: 7,488 units · 185 per 100k residents OK Louisiana: 66,631 units · 1,457 per 100k residents LA Mississippi: 2,100 units · 71.4 per 100k residents MS Alabama: 14,727 units · 288 per 100k residents AL Georgia: 10,595 units · 96.1 per 100k residents GA D.C.: 360 units · 53.0 per 100k residents DC Hawaii: 1,870 units · 130 per 100k residents HI Texas: 44,284 units · 145 per 100k residents TX Florida: 30,711 units · 136 per 100k residents FL
Units reimbursed · per 100k residents
46.72,894
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 Connecticut 2,894 /100k
2 Indiana 1,967 /100k
3 Kentucky 1,933 /100k
4 Ohio 1,485 /100k
5 Louisiana 1,457 /100k
6 Michigan 1,187 /100k
7 Idaho 941 /100k
8 Iowa 746 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 capsules this page72060-0121-40 53,781 Rx · $87,956,097
7 capsules72060-0121-07 No Medicaid data
Drug total (last 4 qtrs): 53,781 Rx · 1,606,442 units · $87,956,097 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Caplyta — 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 Caplyta. 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
$109.39M
Claims incl. refills
63.8K
Beneficiaries
26.7K
Spend / beneficiary
$4,091.85
Spend / claim
$1,714.75
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 Lumateperone — the ingredient across all brands.

Top reported reactions

Dizziness719
Nausea549
Headache488
Somnolence416
Mania284
Anxiety282
Sedation274

Age at onset

Child1
Adolescent2
Adult1,410
Elderly95

Reporter sex

7,088 reports
Male · 31%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization569
Death61
Disabling51
Life-threatening30
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,611 0
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 Per unit Per pack Marketing startStatus
72060-0121-40 You're viewing this 30 CAPSULE in 1 BOTTLE (72060-121-40) $57.23 / ea $1,716.87 2022-08-09 Active
72060-0121-07 7 CAPSULE in 1 BOTTLE (72060-121-07) — — 2023-06-01 Active

You're viewing the largest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 72060-0121-40?
NDC 72060-0121-40 is a 30-count package — 30 capsule in 1 bottle.
What is the difference between NDC 72060-0121-40 and NDC 72060-0121-07?
Both are CAPLYTA lumateperone 21 mg Capsule — the drug itself is identical. NDC 72060-0121-40 is the 30-count package, while NDC 72060-0121-07 is the 7 capsules package.
What NDC number is used to bill for this package of CAPLYTA lumateperone 21 mg Capsule?
Bill NDC 72060-0121-40 — the 11-digit billing format is 72060012140. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 220 words ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS 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. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2) ]. The safety and effectiveness of CAPLYTA have not been established in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ; and SUICIDAL THOUGHTS AND BEHAVIORS 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. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients.

Closely monitor all antidepressant-treated patients for worsening and emergence of suicidal thoughts and behaviors. Safety and effectiveness of CAPLYTA have not been established in pediatric patients . ( 5.2 , 8.4 )

🎯 Indications and Usage 131 words ▾

1 INDICATIONS AND USAGE CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2) ] . Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ].

CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. ( 1 ) Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.

( 1 )

⏱️ Dosage and Administration 166 words ▾

2 DOSAGE AND ADMINISTRATION Recommended oral dosage of CAPLYTA is 42 mg once daily with or without food. ( 2.1 ) Moderate hepatic impairment or severe hepatic impairment: Recommended dosage is 21 mg once daily. ( 2.3 , 8.6 )

2.1Recommended Dosage The recommended CAPLYTA dosage is 42 mg administered orally once daily with or without food. Dose titration is not needed.

2.2Dosage Recommendations for Concomitant Use with Moderate or Strong CYP3A4 Inhibitors The recommended CAPLYTA dosage in patients who receive [see Drug Interactions ( 7.1 ) ] : Strong CYP3A4 inhibitors is 10.5 mg once daily. Moderate CYP3A4 inhibitors is 21 mg once daily.

2.3Dosage Recommendations for Patients with Hepatic Impairment For patients with moderate hepatic impairment (HI) (Child-Pugh class B) or severe HI (Child-Pugh class C), the recommended CAPLYTA dosage is 21 mg once daily [see Use in Specific Populations (8.6) ] . The recommended CAPLYTA dosage in patients with mild HI is the same as those with normal hepatic function.

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS CAPLYTA capsules are available in three strengths: 42 mg: Blue cap and opaque white body imprinted with “ITI-007 42 mg” 21 mg: Opaque white cap and body imprinted with “ITI-007 21 mg” 10.5 mg: Opaque light pink cap and body imprinted with “ITI-007 10.5 mg” Capsules: 42 mg, 21 mg, 10.5 mg ( 3 )

⛔ Contraindications 54 words ▾

4 CONTRAINDICATIONS CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria. CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of CAPLYTA. ( 4 )

⚠️ 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 and transient ischemic attack). ( 5.3 ) Neuroleptic Malignant Syndrome: If NMS is suspected, immediately discontinue CAPLYTA and provide intensive symptomatic treatment and monitoring. ( 5.4 ) Tardive Dyskinesia: If signs and symptoms of TD occur consider discontinuing CAPLYTA treatment.

( 5.5 ) Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. ( 5.6 ) Leukopenia, Neutropenia, and Agranulocytosis : In patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia, perform complete blood counts (CBC). Consider discontinuing CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.

Discontinue CAPLYTA in patients with clinically significant neutropenia or ANC < 1000/mm 3 and monitor closely until the neutropenia resolve. ( 5.7 ) Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure in patients who are vulnerable to hypotension. ( 5.8 ) Seizures: Use cautiously in patients with a history of seizures or with other conditions that lower seizure threshold.

( 5.10 ) Potential for Cognitive and Motor Impairment: Use caution when operating machinery and driving a motor vehicle until patients are reasonably certain that therapy with CAPLYTA does not affect them adversely. ( 5.11 )

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. In an analysis of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, the risk of death in antipsychotic drug-treated patients was 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the incidence of death in antipsychotic-treated patients was about 4.5%, compared to an incidence of about 2.6% in placebo-treated patients.

Although the causes of death varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia). CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Indications and Usage (1) ] .

5.2Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated pediatric and young adult patients was greater than in placebo-treated patients. There were differences in absolute risk of suicidal thoughts and behaviors across the different uses, with the highest incidence in patients with MDD.

The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18-24 years old 5 additional patients Decreases Compared to Placebo 25-64 years old 1 fewer patient > 65 years old 6 fewer patients * CAPLYTA is not approved for use in pediatric patients.

It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay th…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning , Warnings and Precautions (5.1) ] Suicidal Thoughts and Behaviors [see Boxed Warning , Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.7) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.11) ] Body Temperature Dysregulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Most common adverse reactions in clinical trials (incidence ≥ 5% and greater than twice placebo) were ( 6.1 ): Schizophrenia: somnolence/sedation and dry mouth.

Bipolar depression: somnolence/sedation, dizziness, nausea, dry mouth. MDD: dizziness, dry mouth, somnolence/sedation, nausea, fatigue, diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Intra-Cellular Therapies, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CAPLYTA has been evaluated in placebo-controlled clinical trials that included 3575 adult patients with schizophrenia, bipolar depression, or major depressive disorder, exposed to one or more CAPLYTA doses. A total of 852 CAPLYTA-treated patients had at least 6 months of treatment and 108 had at least 1 year of treatment with the 42-mg once daily dosage.

Adverse Reactions in Patients with Schizophrenia The following adverse reactions are based on the pooled short-term (4- to 6-week), placebo-controlled studies in adult patients with schizophrenia in which CAPLYTA was administered at a dosage of 42 mg once daily (N=406) [see Clinical Studies (14.1) ]. There was no single adverse reaction that led to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients. The most common adverse reactions (incidence of at least 5% of CAPLYTA-treated patients and greater than twice the rate of placebo-treated patients) were somnolence/sedation and dry mouth.

Adverse reactions (incidence of at least 2% in CAPLYTA-treated patients and greater than in placebo-treated patients) are shown in Table 2. Table 2: Adverse Reactions Reported in ≥2% of CAPLYTA-Treated Patients and Greater Incidence Than in Placebo-Treated Patients in 4- to 6-week Schizophrenia Trials CAPLYTA 42 mg (N=406) Placebo (N=412) Somnolence/Sedation 24% 10% Nausea 9% 5% Dry Mouth 6% 2% Dizziness 1 5% 3% Creatine Phosphokinase Increased 4% 1% Fatigue 3% 1% Vomiting 3% 2% Hepatic Transaminases Increased 2 2% 1% Decreased Appetite 2% 1% 1 Dizziness, dizziness postural 2 ALT, AST, “hepatic enzymes” increased, or liver function test abnormal Adverse Reactions in Patients with Bipolar Depression (CAPLYTA Monotherapy) The following adverse reactions are based on the pooled short-term (6-week), placebo-controlled monotherapy bipolar depression studies in adult patients treated with CAPLYTA 42 mg once daily (N=372) [see Clinical Studies (14.2) ] .

There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients. The most common adverse reactions (incidence of at least 5% of CAPLYTA-treated…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS CYP3A4 inducers: Avoid concomitant use with CAPLYTA. ( 7.1 ) Strong CYP3A4 inhibitors: Recommended dosage is 10.5 mg once daily. ( 2.2 , 7.1 ) Moderate CYP3A4 inhibitors: Recommended dosage is 21 mg once daily. ( 2.2 , 7.1 )

7.1Drugs Having Clinically Important Interactions with CAPLYTA Clinically important drug interactions with CAPLYTA are presented in Table 6. Table 6: Clinically Important Drug Interactions with CAPLYTA CYP3A4 Inducers* Prevention or Management Avoid concomitant use of CAPLYTA with CYP3A4 inducers . Clinical Impact Concomitant use of CAPLYTA with CYP3A4 inducers decreases the exposure of lumateperone [see Clinical Pharmacology ( 12.3 ) ].

Moderate or Strong CYP3A4 Inhibitors* Prevention or Management Reduce the CAPLYTA dosage when used concomitantly with moderate or strong CYP3A4 inhibitors [see Dosage and Administration ( 2.2 ) ]. Clinical Impact Concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors increases lumateperone exposure [see Clinical Pharmacology ( 12.3 ) ] , which may increase the risk of adverse reactions. Serotonin Reuptake Inhibitors Prevention or Management Increased monitoring for SRI- associated adverse reactions is recommended.

Clinical Impact Although no clinically significant drug interactions with adjunctive SSRI/SNRIs in MDD were observed in CAPLYTA clinical trials, CAPLYTA’s moderate serotonin transporter (SERT) activity may increase the risk of SRI-associated adverse reactions (e.g., serotonin syndrome, hyponatremia). * See www.fda.gov/CYPandTransporterInteractingDrugs for examples of CYP3A4 Inducers and Moderate or Strong CYP3A4 Inhibitors

👥 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 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including CAPLYTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ).

Available data from case reports on CAPLYTA use in pregnant women are insufficient to establish any drug associated risks for birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including CAPLYTA, during pregnancy (see Clinical Considerations ). In animal reproduction studies, no malformations were observed with oral administration of lumateperone to pregnant rats and rabbits during organogenesis at doses up to 2.4 and 9.7 times, respectively, the maximum recommended human dose (MRHD) of 42 mg/day on a mg/m 2 basis.

When pregnant rats were administered lumateperone during the period of organogenesis through lactation, the number of perinatal deaths of pups was increased at 4.9 times the MRHD, with no adverse effects on pups at 2.4 times the MRHD (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

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 Disease Associated Maternal and/or Embryo/fetal Risk: There is risk to the mother from untreated schizophrenia, including increased risk of relapse, hospitalization, and suicide. Schizophrenia is associated with increased adverse perinatal outcomes, including preterm birth.

It is not known if this is a direct result of the illness or other comorbid factors. 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 who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity.

Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Animal Data Pregnant rats were treated with oral doses of 3.5, 10.5, 21, and 63 mg/kg/day lumateperone (0.8, 2.4, 4.9, and 14.6 times the MRHD on a mg/m 2 basis) during the period of organogenesis.

No malformations were observed with lumateperone at doses up to 2.4 times the MRHD. Findings of decreased body weight were observed in fetuses at 4.9 and 14.6 times the MRHD. Findings of incomplete ossification and increased incidences of visceral and skeletal variations were recorded in fetuses at 14.6 times the MRHD, a dose that induced maternal toxicity.

Pregnant rabbits were treated with oral doses of 2.1, 7, and 21 mg/kg/day lumateperone (1.0, 3.2, and 9.7 times the MRHD on a mg/m 2 basis) during the period of organogenesis. Lumateperone did not cause adverse developmental effects at doses up to 9.7 times the MRHD. In a study in which pregnant rats were administered oral doses of 3.5, 10.5, and 21 mg/kg/day lumateperone (0.8, 2.4, and 4.9 times the MRHD on a mg/m 2 basis) during the period of organogenesis and…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including CAPLYTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ).

Available data from case reports on CAPLYTA use in pregnant women are insufficient to establish any drug associated risks for birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including CAPLYTA, during pregnancy (see Clinical Considerations ). In animal reproduction studies, no malformations were observed with oral administration of lumateperone to pregnant rats and rabbits during organogenesis at doses up to 2.4 and 9.7 times, respectively, the maximum recommended human dose (MRHD) of 42 mg/day on a mg/m 2 basis.

When pregnant rats were administered lumateperone during the period of organogenesis through lactation, the number of perinatal deaths of pups was increased at 4.9 times the MRHD, with no adverse effects on pups at 2.4 times the MRHD (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

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 Disease Associated Maternal and/or Embryo/fetal Risk: There is risk to the mother from untreated schizophrenia, including increased risk of relapse, hospitalization, and suicide. Schizophrenia is associated with increased adverse perinatal outcomes, including preterm birth.

It is not known if this is a direct result of the illness or other comorbid factors. 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 who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity.

Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Animal Data Pregnant rats were treated with oral doses of 3.5, 10.5, 21, and 63 mg/kg/day lumateperone (0.8, 2.4, 4.9, and 14.6 times the MRHD on a mg/m 2 basis) during the period of organogenesis.

No malformations were observed with lumateperone at doses up to 2.4 times the MRHD. Findings of decreased body weight were observed in fetuses at 4.9 and 14.6 times the MRHD. Findings of incomplete ossification and increased incidences of visceral and skeletal variations were recorded in fetuses at 14.6 times the MRHD, a dose that induced maternal toxicity.

Pregnant rabbits were treated with oral doses of 2.1, 7, and 21 mg/kg/day lumateperone (1.0, 3.2, and 9.7 times the MRHD on a mg/m 2 basis) during the period of organogenesis. Lumateperone did not cause adverse developmental effects at doses up to 9.7 times the MRHD. In a study in which pregnant rats were administered oral doses of 3.5, 10.5, and 21 mg/kg/day lumateperone (0.8, 2.4, and 4.9 times the MRHD on a mg/m 2 basis) during the period of organogenesis and through lactation, the number of live-born pups was decreased at 2.4 and 4.9 times the MRHD, and early postnatal deaths increased at a dose 4.9…

🧒 Pediatric Use 36 words ▾

8.4Pediatric Use Safety and effectiveness of CAPLYTA have not been established in pediatric patients. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Precautions (5.2) ].

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Controlled clinical studies of CAPLYTA for the treatment of schizophrenia and as adjunctive therapy with antidepressants for the treatment of MDD did not include any patients aged 65 or older to determine whether or not they respond differently from younger adult patients. Among the CAPLYTA-treated patients in clinical studies for the treatment of depressive episodes associated with bipolar depression, 20 (6%) were 65 to 74 years of age, and none were 75 years of age or older [see Clinical Studies (14.2) ].

These clinical studies did not include sufficient numbers of patients aged 65 years of age or older to determine whether or not they respond differently from younger adult patients. Antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning , Warnings and Precautions ( 5.1 ) and ( 5.3 ) ] .

Elderly patients with dementia-related psychosis treated with antipsychotics have an increased risk of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) including fatalities, compared to those treated with placebo [see Warnings and Precautions (5.1) ]. Antipsychotic drugs increase the risk of tardive dyskinesia and this risk appears to be highest among the elderly, particularly elderly women [see Warnings and Precautions (5.5) ]. The use of serotonin reuptake inhibitors (SRIs) has been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction.

The concomitant use of CAPLYTA with an SRI may increase this risk [see Drug Interactions (7.1) ].

🆘 Overdosage 47 words ▾

10 OVERDOSAGE No specific antidotes for CAPLYTA are known. In managing a CAPLYTA overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. 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 lumateperone for the treatment of schizophrenia in adults, for the treatment of depressive episodes associated with bipolar depression (as monotherapy or as adjunctive therapy with lithium or valproate), and as adjunctive therapy with antidepressants for the treatment of MDD is unknown. However, the mechanism of action of lumateperone for these uses could be mediated through a combination of antagonist activity at central serotonin 5-HT 2A receptors, and partial agonist activity at central dopamine D 2 receptors.

12.2Pharmacodynamics Lumateperone has high binding affinity for serotonin 5-HT 2A receptors (K i = 0.54 nM) and moderate binding affinity for dopamine D 2 (K i = 32 nM) receptors. Lumateperone has moderate binding affinity for dopamine D 1 (K i = 41 nM) and D 4 and adrenergic alpha 1A and alpha 1B receptors (K i ≤ 100 nM), serotonin transporters (K i = 33 nM), and inhibits uptake of serotonin in cells expressing the human SERT (IC 50 = 150 nM). Lumateperone has low binding affinity (less than 50% inhibition at 100 nM) for muscarinic and histaminergic receptors.

In healthy human volunteers the mean cortical 5-HT 2A receptor occupancy and the mean striatal D 2 receptor occupancy were greater than 80% and approximately 12%, respectively, after a single 7 mg dose of CAPLYTA. D 2 receptor occupancy increased with a dose from 7 mg to 28 mg. In patients with schizophrenia treated with CAPLYTA 42 mg for 2 weeks, mean dorsal striatal D 2 receptor occupancy was 39%.

Cardiac Electrophysiology QTcF interval was evaluated in a randomized, placebo- and active- (moxifloxacin 400 mg) controlled, four-arm crossover study utilizing concentration-QTc effect modeling in 33 patients with schizophrenia. The placebo-corrected change from baseline QTcF (90% two-sided upper confidence interval) values of 4.9 (8.9) and 15.8 (19.8) ms for a CAPLYTA 42 mg once daily oral dosage for five days and a CAPLYTA 126 mg once daily oral dosage (three times the recommended daily dosage) for five days, respectively.

12.3Pharmacokinetics Following once daily oral administration of CAPLYTA, lumateperone steady state is reached in about 5 days. Lumateperone steady-state exposure is approximately dose-proportional in the range of 3.5 mg to 56 mg (0.08 to 1.3 times the approved recommended daily dosage). A large inter-subject variability in lumateperone PK parameters was observed, with coefficients of variation for C max (peak plasma concentration) and AUC (area under the concentration vs time curve) ranging from 68% to 97% at steady state.

Absorption After CAPLYTA dosing, the absolute bioavailability of lumateperone is about 4.4%. C max of lumateperone is reached approximately 1-2 hours after CAPLYTA dosing. Effect of Food: Ingestion of a high-fat meal with CAPLYTA lowered lumateperone mean C max by 33% and increased mean AUC by 9%.

Median T max was delayed about 1 hour (from 1 hour at fasted state to 2 hours in the presence of food). Distribution Protein binding of lumateperone is 97.4% at 5 µM (about 70-fold higher than therapeutic concentrations) in human plasma. The volume of distribution of lumateperone following intravenous administration is about

4.1L/kg. Elimination The clearance of lumateperone is approximately

27.9L/hour and the terminal half-life is about 18 hours after intravenous administration. Metabolism: Lumateperone is extensively metabolized with more than twenty metabolites identified in vivo . After a single 14 C-labeled oral dose, lumateperone and glucuronidated metabolites represent about 2.8% and 51% of the total plasma radioactivity, respectively.

In vitro studies show that multiple enzymes, including but not limited to uridine 5'-diphospho-glucuronosyltransferases (UDP-glucuronosyltransferase, UGT) 1A1, 1A4, and 2B15, aldoketoreductase (AKR)1C1, 1B10, and 1C4, and cytochrome P450 (CYP) 3A4, 2C8, and 1A2, are involved in the metabolism of lumateperone. Excr…

🧬 Mechanism of Action 85 words ▾

12.1Mechanism of Action The mechanism of action of lumateperone for the treatment of schizophrenia in adults, for the treatment of depressive episodes associated with bipolar depression (as monotherapy or as adjunctive therapy with lithium or valproate), and as adjunctive therapy with antidepressants for the treatment of MDD is unknown. However, the mechanism of action of lumateperone for these uses could be mediated through a combination of antagonist activity at central serotonin 5-HT 2A receptors, and partial agonist activity at central dopamine D 2 receptors.

📦 How Supplied / Storage and Handling 93 words ▾

16 HOW SUPPLIED/ STORAGE AND HANDLING CAPLYTA (lumateperone) capsules are supplied as follows: Capsule Strength Capsule Color Imprint Codes Package Configuration NDC Code 42 mg Blue cap and opaque white body ITI-007 42 mg Bottle of 30 72060-142-40 21 mg Opaque white cap and body ITI-007 21 mg Bottle of 30 72060-121-40 10.5 mg Opaque light pink cap and body ITI-007 10.5 mg Bottle of 30 72060-110-40 Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

📋 Description 150 words ▾

11 DESCRIPTION Lumateperone is an atypical antipsychotic present as lumateperone tosylate salt with the chemical name 4-((6b R ,10a S )-3-methyl-2,3,6b,9,10,10 a -hexahydro-1 H ,7 H -pyrido[3',4':4,5]pyrrolo[1,2,3- de ]quinoxalin-8-yl)-1-(4-fluoro-phenyl)-butan-1-one 4-methylbenzenesulfonate. Its molecular formula is C 31 H 36 FN 3 O 4 S, and its molecular weight is 565.71 g/mol with the following structure: CAPLYTA (lumateperone) capsules are for oral administration. Each capsule contains: 42 mg of lumateperone (equivalent to 60 mg of lumateperone tosylate), or 21 mg of lumateperone (equivalent to 30 mg of lumateperone tosylate), or 10.5 mg of lumateperone (equivalent to 15 mg of lumateperone tosylate).

The capsules include the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, and talc. Colorants include FD&C blue #1 and red #3 (42 mg), FDA/E172 black iron oxide, FDA/E172 red iron oxide and FD&C red #3 (10.5 mg), and titanium dioxide (42 mg, 21 mg and 10.5 mg). Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behavior Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during CAPLYTA treatment and instruct them to report such symptoms to their healthcare provider [see Boxed Warning, Warnings and Precautions (5.2) ]. Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal neuroleptic malignant syndrome (NMS), that has been reported with administration of antipsychotic drugs.

Advise patients, family members, or 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 about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions (5.6) ].

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 CAPLYTA [see Warnings and Precautions (5.7) ]. Orthostatic Hypotension and Syncope Educate patients about the risk of orthostatic hypotension and syncope, especially early in treatment, and also at times of re-initiating treatment [see Warnings and Precautions (5.8) ]. Effects on Driving and Operating Heavy Machinery Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that CAPLYTA therapy does not affect them adversely [see Warnings and Precautions (5.11) ].

Heat Exposure and Dehydration Educate patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.12) ]. Concomitant Drugs Advise patients to inform their health care providers of any changes to their current prescription or over-the-counter drugs because there is a potential for clinically significant interactions [see Drug Interactions (7.1) ]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with CAPLYTA.

Advise patients that CAPLYTA used during the third trimester may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in the neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to CAPLYTA during pregnancy [see Use in Specific Populations (8.1) ]. Infertility Advise males and females of reproductive potential that CAPLYTA may impair fertility [see Use in Specific Populations (8.3) ].

Distributed by Intra-Cellular Therapies, Inc. Titusville, NJ 08560 CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc. © 2026 Intra-Cellular Therapies, Inc. All rights reserved.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2026 MEDICATION GUIDE CAPLYTA (kap-LITE-ah) (lumateperone) capsules, for oral use What is the most important information I should know about CAPLYTA?

CAPLYTA may cause serious side effects, including : Increased risk of death in elderly people with dementia related psychosis. Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for the treatment of people with dementia-related psychosis.

Increased risk of suicidal thoughts and actions. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or the antidepressant medicine is started or when the dose is changed.

Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling very agitated or restless trouble sleeping acting aggressive, being angry, or violent an extreme increase in activity and talking (mania) suicide attempts new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood See “ What are the possible side effects of CAPLYTA? ” for more information about side effects.

What is CAPLYTA? CAPLYTA is a prescription medicine used in adults: to treat schizophrenia alone or along with the medicine lithium or valproate to treat depressive episodes that happen with bipolar I or bipolar II disorder (bipolar depression) along with antidepressant medicines to treat major depressive disorder (MDD) It is not known if CAPLYTA is safe and effective in children. Who should not take CAPLYTA?

Do not take CAPLYTA if you: are allergic to lumateperone or any of the ingredients in CAPLYTA. See the end of this Medication Guide for a complete list of ingredients in CAPLYTA. Before taking CAPLYTA, tell your healthcare provider about all of your medical conditions, including if you: have or have had heart problems or a stroke have or have had low or high blood pressure have or have had diabetes or high blood sugar, or a family history of diabetes or high blood sugar. have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides or low levels of HDL cholesterol have or have had a low white blood cell count have or have had seizures (convulsions) have or have had kidney or liver problems are pregnant or plan to become pregnant.

CAPLYTA may harm your unborn baby. Taking CAPLYTA during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take CAPLYTA during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. If you become pregnant during treatment with CAPLYTA, talk to your healthcare provider about registering with the Natio…

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