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: N208658

Product 004
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE (SYNJARDY XR) TABLET, EXTENDED RELEASE 25MG;1GM

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
004	7579449	08/01/2028	DS				01/04/2017
004	7579449*PED	02/01/2029
004	7713938	04/15/2027	DS	DP			01/04/2017
004	7713938*PED	10/15/2027
004	9949997	05/17/2034			U-3532 U-3533		03/01/2023
004	9949997*PED	11/17/2034
004	9949998	06/11/2034			U-2290		05/16/2018
004	9949998*PED	12/11/2034
004	10258637	04/03/2034			U-2290		04/30/2019
004	10258637*PED	10/03/2034
004	10596120	03/07/2032		DP	U-2775 U-2792		04/20/2020
004	10596120*PED	09/07/2032
004	11090323	04/03/2034			U-3193		08/20/2021
004	11090323*PED	10/03/2034
004	11833166	04/03/2034			U-3776 U-3777		01/03/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
004	M-296	06/20/2026
004	M-296 *PED	12/20/2026

 

 

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