CAPLYTA Drug Patent Profile
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When do Caplyta patents expire, and what generic alternatives are available?
Caplyta is a drug marketed by Intra-cellular and is included in one NDA. There are twenty-three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-four patent family members in twenty countries.
The generic ingredient in CAPLYTA is lumateperone tosylate. One supplier is listed for this compound. Additional details are available on the lumateperone tosylate profile page.
DrugPatentWatch® Generic Entry Outlook for Caplyta
Caplyta was eligible for patent challenges on December 20, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 30, 2039. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for CAPLYTA?
- What are the global sales for CAPLYTA?
- What is Average Wholesale Price for CAPLYTA?
Summary for CAPLYTA
International Patents: | 164 |
US Patents: | 23 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 3 |
Patent Applications: | 18 |
Drug Prices: | Drug price information for CAPLYTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CAPLYTA |
What excipients (inactive ingredients) are in CAPLYTA? | CAPLYTA excipients list |
DailyMed Link: | CAPLYTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CAPLYTA
Generic Entry Date for CAPLYTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for CAPLYTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Intra-Cellular Therapies, Inc. | Phase 4 |
University of Massachusetts, Worcester | Phase 4 |
University of New Mexico | Phase 4 |
Pharmacology for CAPLYTA
Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for CAPLYTA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CAPLYTA | Capsules | lumateperone tosylate | 42 mg | 209500 | 7 | 2023-12-20 |
US Patents and Regulatory Information for CAPLYTA
CAPLYTA is protected by thirty-two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CAPLYTA is ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-003 | Apr 22, 2022 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for CAPLYTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | ⤷ Subscribe | ⤷ Subscribe |
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CAPLYTA
When does loss-of-exclusivity occur for CAPLYTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 19331490
Patent: Novel methods
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2021003838
Patent: métodos novos
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 08558
Patent: NOUVELLES METHODES (NOVEL METHODS)
Estimated Expiration: ⤷ Subscribe
China
Patent: 2584838
Patent: 新方法 (NOVEL METHODS)
Estimated Expiration: ⤷ Subscribe
Patent: 8873536
Patent: 新方法
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 43739
Patent: NOUVELLES MÉTHODES (NOVEL METHODS)
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 0913
Patent: שיטות חדשות (Novel methods)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 57000
Estimated Expiration: ⤷ Subscribe
Patent: 21535151
Patent: 新規方法
Estimated Expiration: ⤷ Subscribe
Patent: 24073559
Patent: 新規方法 (NOVEL METHODS)
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 21002321
Patent: NUEVOS METODOS. (NOVEL METHODS.)
Estimated Expiration: ⤷ Subscribe
Patent: 24010140
Patent: NUEVOS METODOS. (NOVEL METHODS.)
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 210052472
Patent: 신규한 방법
Estimated Expiration: ⤷ Subscribe
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering CAPLYTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2725342 | GAMMA-CARBOLINES FUSIONNEES A HETEROCYCLE SUBSTITUE POUR LES TROUBLES DU SOMMEIL ET AUTRES TROUBLES (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES FOR SLEEP DISORDERS AND OTHER DISORDERS) | ⤷ Subscribe |
China | 118873536 | 新方法 | ⤷ Subscribe |
Mexico | 2024010140 | NUEVOS METODOS. (NOVEL METHODS.) | ⤷ Subscribe |
Germany | 60014370 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
CAPLYTA Market Analysis and Financial Projection Experimental
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