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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 002
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE (QTERN) TABLET 5MG;EQ 5MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6515117 10/04/2025 DS DP U-493 05/24/2019
002 7919598 12/16/2029 DS 05/24/2019
002 8221786 03/21/2028 DP 05/24/2019
002 8361972 03/21/2028 U-493 05/24/2019
002 8501698 06/20/2027 DP U-493 05/24/2019
002 8628799 07/13/2025 DP 05/24/2019
002 8716251 03/21/2028 DP 05/24/2019
002 RE44186 07/31/2023 DS DP U-493 05/24/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002 NS 05/02/2022

 

 


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