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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: N212614

Product 003
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE (TRIJARDY XR) TABLET, EXTENDED RELEASE 12.5MG;2.5MG;1GM

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 7407955 05/02/2025 DS DP 02/18/2020
003 7579449 08/01/2028 DS 02/18/2020
003 7713938 04/15/2027 DS DP 02/18/2020
003 8119648 08/12/2023 U-1652 02/18/2020
003 8178541 08/12/2023 DP U-1652 02/18/2020
003 8551957 10/14/2029 DP U-2730 02/18/2020
003 8883805 11/26/2025 DP 02/18/2020
003 9155705 05/21/2030 DP 02/18/2020
003 9415016 04/02/2029 DP 02/18/2020
003 9949998 06/11/2034 U-2731 02/18/2020
003 10022379 04/02/2029 DP U-2732 02/18/2020
003 10258637 04/03/2034 U-2731 02/18/2020
003 10406172 06/15/2030 DP U-2733 02/18/2020
003 10596120 03/07/2032 DP U-2776 U-2790 04/21/2020
003 11090323 04/03/2034 U-3192 08/20/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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