Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

• Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
• Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
• As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N209500

Product 002
LUMATEPERONE TOSYLATE (CAPLYTA) CAPSULE EQ 10.5MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	8648077	12/01/2029	DS	DP			05/18/2022
002	9168258	05/27/2029		DP			12/12/2023
002	9199995	03/12/2029			U-2713		05/18/2022
002	9616061	05/27/2029		DP			05/18/2022
002	9956227	12/03/2034			U-2714		05/18/2022
002	10117867	05/27/2029			U-3271		05/18/2022
002	10464938	03/12/2028		DP			05/18/2022
002	10695345	08/30/2039		DP	U-814		05/18/2022
002	11026951	12/03/2034			U-3364		05/18/2022
002	11052084	08/30/2039		DP	U-3362 U-3363		05/18/2022
002	11690842	08/30/2039		DP	U-3362 U-3363		08/03/2023
002	11753419	12/10/2040		DP			10/11/2023
002	11806348	08/30/2039		DP	U-3362 U-3363		11/17/2023
002	RE48825	02/12/2029	DS				05/18/2022
002	RE48839	08/19/2033			U-814 U-3271		05/18/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	NCE	12/20/2024

 

 

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