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: N215814

Product 001
OLUTASIDENIB (REZLIDHIA) CAPSULE 150MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9834539	09/18/2035	DS	DP	U-3497		01/03/2023
001	10414752	09/18/2035		DP			01/03/2023
001	10532047	05/16/2039	DS				01/03/2023
001	10550098	09/18/2035		DP			01/03/2023
001	10959994	05/16/2039		DP			01/03/2023
001	11013733	05/16/2039			U-3496		01/03/2023
001	11013734	05/16/2039			U-3495		01/03/2023
001	11376246	05/16/2039			U-3495		01/03/2023
001	11497743	05/16/2039			U-3495		01/03/2023
001	11498913	09/18/2035		DP			01/03/2023
001	11723905	11/12/2039		DP			09/14/2023
001	11738018	07/17/2039			U-3684		09/14/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	12/01/2027
001	ODE-413	12/01/2029

 

 

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