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: N202270

Product 002
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE (JANUMET XR) TABLET, EXTENDED RELEASE 1GM;EQ 50MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6699871 07/26/2022 DS DP
U-1227 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
002 6699871*PED 01/26/2023
002 7125873 07/26/2022 DP
U-1227 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
002 7125873*PED 01/26/2023
002 7326708 11/24/2026 DS DP
U-1227 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
002 7326708*PED 05/24/2027

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
M-244INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
COMPETITIVE GENERIC THERAPY
08/12/2022
002
M-244INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
*PED PEDIATRIC EXCLUSIVITY
02/12/2023
002
M-187ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
COMPETITIVE GENERIC THERAPY
12/04/2023
002
M-187ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
*PED PEDIATRIC EXCLUSIVITY
06/04/2024

 

 


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