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Last Updated: May 1, 2024

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 two suppliers. There are eighteen patents protecting this drug. Additional details are available on the CAPLYTA profile page.

The generic ingredient in CAPLYTA is lumateperone tosylate. Two suppliers are 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:	18

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

Generic Entry Date for 209500^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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	REMEDYREPACK INC.	70518-3497	70518-3497-0	30 POUCH in 1 BOX (70518-3497-0) / 1 CAPSULE in 1 POUCH (70518-3497-1)
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:	⤷ Try a Trial	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	⤷ Try a Trial	⤷ Try a Trial
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.