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: N202293

Product 001
DAPAGLIFLOZIN (FARXIGA) TABLET 5MG

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 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
02/05/2014
001 7456254 06/30/2025 DP
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
11/15/2017
001 7851502 08/19/2028 DP
02/05/2014
001 7919598 12/16/2029 DS
02/05/2014
001 8221786 03/21/2028 DP
02/05/2014
001 8329648 08/18/2026
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
U-2212 REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
U-2213 REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
11/15/2017
001 8361972 03/21/2028
U-493 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
02/05/2014
001 8431685 04/13/2025 DP
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
11/15/2017
001 8461105 04/13/2025 DP
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
11/15/2017
001 8501698 06/20/2027 DP
U-493 TREATMENT OF TYPE 2 DIABETES MELLITUS
02/05/2014
001 8685934 05/26/2030
U-1522 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
06/25/2014
001 8716251 03/21/2028 DP
06/02/2014
001 8721615 01/18/2030 DP
Y 11/15/2017
001 8906851 08/18/2026
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
11/15/2017
001 9238076 04/15/2024 DP
U-2139 TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
11/15/2017

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
M-238INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT
COMPETITIVE GENERIC THERAPY
02/22/2022
001
I-841TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
COMPETITIVE GENERIC THERAPY
10/18/2022
001
I-834TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION
COMPETITIVE GENERIC THERAPY
05/05/2023
001
I-857TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
COMPETITIVE GENERIC THERAPY
04/30/2024

 

 


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