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: N209360

Product 001
ANGIOTENSIN II ACETATE (GIAPREZA) SOLUTION EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9220745	12/18/2034			U-2217 U-2218		01/22/2018
001	9572856	07/18/2031			U-2221		01/22/2018
001	9867863	12/16/2029			U-2231		02/14/2018
001	10028995	12/18/2034			U-2338		08/02/2018
001	10335451	12/16/2029			U-2581		07/26/2019
001	10493124	12/18/2034			U-2679		12/20/2019
001	10500247	12/16/2029			U-2680 U-2681		12/20/2019
001	10548943	12/16/2029			U-2739 U-2740		02/20/2020
001	11096983	12/18/2034			U-3211 U-3212		09/23/2021
001	11219662	01/06/2037			U-3262		01/11/2022
001	11559559	12/18/2034			U-3514		02/08/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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