Last Updated: November 5, 2026

Lumateperone - Generic Drug Details

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Generic filers with tentative approvals for LUMATEPERONE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	28MG	CAPSULE
⤷ Start Trial	⤷ Start Trial	14MG	CAPSULE
⤷ Start Trial	⤷ Start Trial	42MG	CAPSULE

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for Lumateperone

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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	209500-003	Apr 22, 2022		RX	Yes	No	9,616,061	⤷ Start Trial	Y			⤷ Start Trial
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	11,980,617	⤷ Start Trial				⤷ Start Trial
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	RE48825	⤷ Start Trial		Y		⤷ Start Trial
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	9,616,061	⤷ Start Trial	Y			⤷ Start Trial
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	10,464,938	⤷ Start Trial	Y			⤷ Start Trial
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	12,409,176	⤷ Start Trial				⤷ Start Trial
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	10,695,345	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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