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: N209091

Product 001
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE (QTERN) TABLET 10MG;EQ 5MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	6515117	10/04/2025	DS	DP	U-493		03/22/2017
001	7919598	12/16/2029	DS				03/22/2017
001	8221786	03/21/2028		DP			03/22/2017
001	8361972	03/21/2028			U-493 U-1976 U-1977		03/22/2017
001	8501698	06/20/2027		DP	U-493 U-1976 U-1977		03/22/2017
001	8628799	07/13/2025		DP			03/22/2017
001	8716251	03/21/2028		DP			03/22/2017

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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