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: N209241

Product 002
VALBENAZINE TOSYLATE (INGREZZA) CAPSULE EQ 80MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	8039627	04/11/2031	DS	DP			10/27/2017
002	8357697	11/08/2027			U-1995 U-3055		10/27/2017
002	10065952	10/28/2036	DS	DP	U-1995 U-3055		09/26/2018
002	10844058	10/28/2036	DS	DP	U-1995 U-3055		12/18/2020
002	10851103	10/28/2036	DS	DP	U-1995 U-3055		12/18/2020
002	10851104	10/28/2036	DS		U-1995 U-3055		12/18/2020
002	10857137	10/10/2037			U-1995		12/18/2020
002	10857148	10/10/2037			U-1995		12/18/2020
002	10874648	10/10/2037			U-1995 U-3046 U-3055		01/25/2021
002	10906902	12/22/2036	DS	DP			03/03/2021
002	10906903	12/22/2036	DS	DP			03/03/2021
002	10912771	10/10/2037			U-1995 U-3055 U-3076		03/03/2021
002	10919892	12/22/2036	DS	DP			03/03/2021
002	10940141	08/10/2040			U-1995		04/06/2021
002	10952997	10/10/2037			U-1995		04/06/2021
002	10993941	10/10/2037			U-1995		05/19/2021
002	11026931	08/14/2039			U-1995		06/30/2021
002	11026939	09/18/2038		DP	U-1995 U-3055		06/30/2021
002	11040029	10/10/2037			U-1995		06/30/2021
002	11311532	09/18/2038		DP	U-1995 U-3055		05/17/2022
002	11439629	10/10/2037			U-3055		09/14/2023
002	11654142	11/14/2038			U-3055		09/14/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	I-925	08/18/2026
002	ODE-440	08/18/2030

 

 

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