Caplyta Generic: When Will Generic Lumateperone Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Caplyta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2040 About 13.5 years away Why then?
- Has the FDA approved a generic? Not yet 2 companies hold tentative approvals Why not yet?
- When does the last patent end? December 2040 25 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic lumateperone tosylate is expected to be available in July 2040, about 13.5 years away. None is for sale yet.
Why July 2040?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If Caplyta’s last patent runs to December 2040, how can a generic come sooner?
The 3 patents that run past the expected month, to December 2040 (11,753,419, 12,122,792 and 12,410,195), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Caplyta’s patents with the FDA since December 2023. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. 2 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Msn Laboratories Private Ltd (May 2025) and Hetero Labs Limited (May 2025). See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 7 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $57.24 pharmacies pay per capsule for Caplyta today to under $2.86. See the price estimate
What should I do now?
Keep taking Caplyta as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Caplyta by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Very strong 7 companies have filed, 7 first in line
- Brand sales
- $1.2B a yearBlockbuster
- FDA approved 2019 December 2019 FDA Orange Book
- Patents listed 25 last runs to December 2040 A generic is expected sooner, in July 2040. See why FDA Orange Book
- Pharmacies pay $57.24 per capsule, up 8% in a year NADAC, October 2026
- Medicare Part D spent $351.2M in 2025, for 35.9K people CMS Part D Spending by Drug
- Medicaid prescriptions 276.5K in the last four reported quarters, $464.6M CMS Medicaid drug utilization, to Q1 2026
Caplyta’s Road to a Generic
Caplyta has had the market to itself since the FDA approved it in December 2019 (Intra-cellular Therapies Inc). Its FDA protection (new clinical information) runs to April 2029. Its 25 listed patents run to December 2040. Generic companies have challenged its patents with the FDA since December 2023.
The first generic of Caplyta is expected in July 2040.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is a few months before the last listed patent runs out, in December 2040.
Why a Generic Can Come Before December 2040
The last listed patent runs to December 2040, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Caplyta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Caplyta’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,464,938 | The product’s formulation | March 2028 | Active |
| 9,199,995 | A way of using it (U-2713, U-4343) | March 2029 | Active |
| 9,586,960 | The active ingredient; the product’s formulation | March 2029 | Active |
| RE48825 | The active ingredient; the product’s formulation | March 2029 | Active |
| 9,168,258 | The product’s formulation | May 2029 | Active |
| 9,616,061 | The product’s formulation | May 2029 | Active |
| 10,117,867 | A way of using it (U-3271) | May 2029 | Active |
| 8,648,077 | The active ingredient; the product’s formulation | December 2029 | Active |
| 8,598,119 | A way of using it (U-543) | December 2029 | Active delisting requested |
| RE48839 | A way of using it (U-4344, U-3271, U-814) | August 2033 | Active |
| 9,956,227 | A way of using it (U-2714) | December 2034 | Active |
| 10,960,009 | A way of using it (U-814) | December 2034 | Active |
| 11,026,951 | A way of using it (U-3274, U-3364) | December 2034 | Active |
| 12,409,176 | A way of using it (U-4261) | March 2039 | Active |
| 10,695,345 | The product’s formulation; a way of using it (U-543, U-814) | August 2039 | Active |
| 11,052,084 | The product’s formulation; a way of using it (U-4341, U-3362, U-3363) | August 2039 | Active |
| 11,690,842 | The product’s formulation; a way of using it (U-4341, U-3362, U-3363) | August 2039 | Active |
| 11,806,348 | The product’s formulation; a way of using it (U-3362, U-3363, U-4341) | August 2039 | Active |
| 12,070,459 | The product’s formulation; a way of using it (U-3362, U-3363, U-4341) | August 2039 | Active |
| 12,128,043 | The product’s formulation; a way of using it (U-3362, U-3363) | August 2039 | Active |
| 11,980,617 | A way of using it (U-4342, U-3940) | October 2039 | Active |
| 12,090,155 | The product’s formulation; a way of using it (U-4000) | July 2040 | Active |
| 11,753,419 | The product’s formulation | December 2040 | Active delisting requested |
| 12,122,792 | The product’s formulation; a way of using it (U-4019, U-4020, U-4340) | December 2040 | Active |
| 12,410,195 | The product’s formulation | December 2040 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-904 | Three years of protection for a newly approved use (indication). | November 2028 | Active |
| New clinical information M-319 | Three years of protection for a change backed by new clinical studies. | April 2029 | Active |
Source: FDA Orange Book, application 209500. Patent numbers open the patent on Google Patents.
Patent Challenges to Caplyta
The first patent challenge to Caplyta reached the FDA in December 2023, from 6 companies on that first day. The FDA’s list has 2 entries for Caplyta, by form and strength. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Caplyta’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Capsules, 10.5 mg and 21 mg | December 2023 | 6 companies | No decision yet | Not yet | Not yet | December 2040 |
| Capsules, 42 mg | December 2023 | 7 companies | No decision yet | Not yet | Not yet | December 2040 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Lumateperone Tosylate
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
7 companies have applied to the FDA to make generic lumateperone tosylate.
The FDA has tentatively approved 2 companies’ generics: Msn Laboratories Private Ltd (May 2025) and Hetero Labs Limited (May 2025). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 7 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Caplyta’s patents with the FDA since December 2023: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic lumateperone tosylate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic lumateperone tosylate for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Caplyta Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Caplyta 10.5 mg capsule
$57.24 per capsule in October 2026, up 8% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Caplyta 10.5 mg capsule $57.24 per capsule
- Caplyta 21 mg capsule $57.20 per capsule
- Caplyta 42 mg capsule $57.25 per capsule
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $57.24 |
| September 2026 | $57.24 |
| August 2026 | $57.27 |
| July 2026 | $57.27 |
| June 2026 | $57.29 |
| May 2026 | $57.29 |
| April 2026 | $57.40 |
| March 2026 | $57.40 |
| February 2026 | $57.40 |
| January 2026 | $57.40 |
| February 2024 | $53.02 |
| January 2024 | $53.02 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Caplyta today: $57.24 per capsule for Caplyta 10.5 mg capsule in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017). Caplyta has 7 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $57.24 pharmacies pay per capsule today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Caplyta
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Caplyta, before manufacturer rebates.
- $109.4M
- January to March 2026, the latest CMS has posted
For 26,733 people, about $1,715 per prescription fill - $351.2M
- 2025, the whole year
For 35,880 people, about $1,669 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $109,387,497 | 26,733 | $1,714.75 |
| 2025 | $351,195,165 | 35,880 | $1,668.90 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Caplyta only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain mental/mood disorders (such as schizophrenia, episodes of depression associated with bipolar disorder). It may also be used in combination with other medications to treat depression.
Medicaid Prescriptions by Quarter
276,511 prescriptions in the four quarters to Q1 2026, $464.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 77,755 | $133,976,814 |
| Q4 2025 | 71,463 | $119,184,490 |
| Q3 2025 | 66,646 | $110,917,273 |
| Q2 2025 | 60,647 | $100,530,294 |
| Q1 2025 | 57,127 | $94,548,440 |
Source: CMS Medicaid State Drug Utilization Data, over Caplyta’s own package codes.
Caplyta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 42MG BASE | Capsule | Oral | December 2019 | Prescription reference product |
| EQ 10.5MG BASE | Capsule | Oral | April 2022 | Prescription reference product |
| EQ 21MG BASE | Capsule | Oral | April 2022 | Prescription reference product |
Source: FDA Orange Book, Intra-cellular Therapies Inc. Listed for sale today by Remedyrepack Inc. and Intra-Cellular Therapies, Inc (FDA NDC Directory).
Caplyta NDC Codes and Packages
Each Caplyta package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 70518-3497-00 | 42 mg capsule | box of 30 pouches of 1 capsule | Remedyrepack Inc. |
| 72060-0110-07 | LUMATEPERONE 10.5 mg/1 capsule | bottle of 7 capsules | Intra-Cellular Therapies, Inc |
| 72060-0110-40 | LUMATEPERONE 10.5 mg/1 capsule | bottle of 30 capsules | Intra-Cellular Therapies, Inc |
| 72060-0110-40 | LUMATEPERONE 10.5 mg/1 capsule | bottle of 30 capsules | Intra-Cellular Therapies, Inc |
| 72060-0121-07 | LUMATEPERONE 21 mg/1 capsule | bottle of 7 capsules | Intra-Cellular Therapies, Inc |
| 72060-0121-40 | LUMATEPERONE 21 mg/1 capsule | bottle of 30 capsules | Intra-Cellular Therapies, Inc |
| 72060-0121-40 | LUMATEPERONE 21 mg/1 capsule | bottle of 30 capsules | Intra-Cellular Therapies, Inc |
| 72060-0142-07 | LUMATEPERONE 42 mg/1 capsule | bottle of 7 capsules | Intra-Cellular Therapies, Inc |
Show the other 3 Caplyta packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 72060-0142-30 | LUMATEPERONE 42 mg/1 capsule | carton of 3 blister packs of 10 capsules | Intra-Cellular Therapies, Inc |
| 72060-0142-40 | LUMATEPERONE 42 mg/1 capsule | bottle of 30 capsules | Intra-Cellular Therapies, Inc |
| 72060-0142-40 | LUMATEPERONE 42 mg/1 capsule | bottle of 30 capsules | Intra-Cellular Therapies, Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Caplyta’s own FDA approval (NDA 209500) are listed, never a generic. Some codes belong to companies that repackage Caplyta: it is the same medicine in a different package.
What a Generic Caplyta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Caplyta as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Caplyta”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Caplyta
Is there a generic for Caplyta right now?
No. As of October 9, 2026 no generic lumateperone tosylate is listed for sale in the FDA NDC Directory.
When will Caplyta go generic?
July 2040 is the expected month, and that is likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to December 2040, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic lumateperone tosylate be the same as Caplyta?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 7 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $57.24 pharmacies pay per capsule for Caplyta today to under $2.86. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Caplyta?
Not yet. The FDA Orange Book lists no approved generic version of Caplyta.
When does the Caplyta patent expire?
The FDA Orange Book lists 25 patents for Caplyta; the last runs to December 2040. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (July 2040) weighs all of that.
Has anyone challenged the Caplyta patents?
Yes. The first patent challenge to Caplyta reached the FDA in December 2023, from 6 companies on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Caplyta cost now?
Pharmacies paid about $57.24 per capsule for Caplyta 10.5 mg capsule in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected July 2040 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
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- VtamaTapinarof2036 to 2037
- OnivydeIrinotecanOctober 2036
- Sotalol Hydrochloride IVSotalol HydrochlorideTBD no date yet
About Caplyta
- Generic name lumateperone tosylate
- How it is taken By mouth
- Company Intra-cellular Therapies Inc
- Patent challenges Since December 2023 (FDA)
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Caplyta
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.