Details for New Drug Application (NDA): 209500

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NDA 209500 describes CAPLYTA, which is a drug marketed by Intra-cellular and is included in one NDA. It is available from one supplier. There are twenty-three patents protecting this drug. Additional details are available on the CAPLYTA profile page.

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.

Summary for 209500

Tradename:	CAPLYTA
Applicant:	Intra-cellular
Ingredient:	lumateperone tosylate
Patents:	23

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209500

Generic Entry Date for 209500^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,695,345 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.

Pharmacology for NDA: 209500

Suppliers and Packaging for NDA: 209500

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500	NDA	Intra-Cellular Therapies, Inc	72060-110	72060-110-07	7 CAPSULE in 1 BOTTLE (72060-110-07)
CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500	NDA	Intra-Cellular Therapies, Inc	72060-110	72060-110-40	30 CAPSULE in 1 BOTTLE (72060-110-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 42MG BASE
Approval Date:	Dec 20, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 17, 2024
Regulatory Exclusivity Use:	INDICATED FOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I OR II DISORDER (BIPOLAR DEPRESSION) IN ADULTS, AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE
Regulatory Exclusivity Expiration:	Dec 20, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	10,117,867	Patent Expiration:	May 27, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF BIPOLAR DEPRESSION

Expired US Patents for NDA 209500

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019	7,183,282	⤷ Subscribe
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019	RE39680	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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