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: N211810

Product 002
PEXIDARTINIB HYDROCHLORIDE (TURALIO) CAPSULE EQ 125MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7893075	05/04/2033	DS				11/14/2022
002	8404700	11/21/2027	DS				11/14/2022
002	8461169	04/19/2028			U-2606		11/14/2022
002	8722702	11/21/2027	DS				11/14/2022
002	9169250	11/21/2027	DS				11/14/2022
002	9358235	06/08/2033			U-2606		11/14/2022
002	9802932	05/05/2036	DS				11/14/2022
002	10189833	05/05/2036			U-2606		11/14/2022
002	10435404	07/24/2038		DP			11/14/2022
002	10730876	05/05/2036	DS				11/14/2022
002	10941142	07/24/2038		DP			11/14/2022
002	10961240	07/24/2038			U-2606		11/14/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	NCE	08/02/2024
002	ODE*	08/02/2026

 

 

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