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 001
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE (TRIJARDY XR) TABLET, EXTENDED RELEASE 5MG;2.5MG;1GM

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7407955 05/02/2025 DS DP
02/18/2020
001 7579449 08/01/2028 DS
02/18/2020
001 7713938 04/15/2027 DS DP
02/18/2020
001 8119648 08/12/2023
U-1652 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
02/18/2020
001 8178541 08/12/2023 DP
U-1652 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
02/18/2020
001 8551957 10/14/2029 DP
U-2730 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
02/18/2020
001 8883805 11/26/2025 DP
02/18/2020
001 9155705 05/21/2030 DP
02/18/2020
001 9415016 04/02/2029 DP
02/18/2020
001 9949998 06/11/2034
U-2731 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
02/18/2020
001 10022379 04/02/2029 DP
U-2732 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
02/18/2020
001 10258637 04/03/2034
U-2731 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
02/18/2020
001 10406172 06/15/2030 DP
U-2733 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
02/18/2020
001 10596120 03/07/2032 DP
U-2776 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
U-2790 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISINGMETFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
04/21/2020
001 11090323 04/03/2034
U-3192 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
08/20/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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