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Last Updated: June 21, 2021

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CAPLYTA Drug 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 eight patents protecting this drug.

This drug has ninety-six patent family members in eighteen countries.

The generic ingredient in CAPLYTA is lumateperone tosylate. Additional details are available on the lumateperone tosylate profile page.

DrugPatentWatch® Generic Entry Outlook for Caplyta

Caplyta will be eligible for patent challenges on December 20, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for CAPLYTA
Drug patent expirations by year for CAPLYTA
Drug Prices for CAPLYTA

See drug prices for CAPLYTA

DrugPatentWatch® Estimated Generic Entry Opportunity 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.

US Patents and Regulatory Information for CAPLYTA

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   Get Started Free   Get Started Free   Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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   Get Started Free   Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
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Boehringer Ingelheim
McKesson

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