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: N212018

Product 002
ERDAFITINIB (BALVERSA) TABLET 4MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	8895601	04/12/2033	DS	DP			05/03/2019
002	9464071	04/28/2031			U-3805		05/03/2019
002	9902714	03/26/2035		DP			05/03/2019
002	10898482	02/09/2036		DP	U-2518 U-3065 U-3066 U-3067 U-3805 U-3806 U-3807		02/19/2021
002	11077106	02/02/2038			U-3196 U-3808		08/27/2021
002	11684620	02/09/2036			U-3805 U-3806 U-3807		07/26/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	NCE	04/12/2024
002	I-930	01/19/2027

 

 

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