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Generic Januvia Availability

Last updated on Sep 8, 2022.

Januvia is a brand name of sitagliptin, approved by the FDA in the following formulation(s):

JANUVIA (sitagliptin phosphate - tablet;oral)

  • Manufacturer: MERCK SHARP DOHME
    Approval date: October 16, 2006
    Strength(s): EQ 25MG BASE [RLD], EQ 50MG BASE [RLD], EQ 100MG BASE [RLD]

Has a generic version of Januvia been approved?

No. There is currently no therapeutically equivalent version of Januvia available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Januvia. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
    Patent 6,699,871
    Issued: March 2, 2004
    Inventor(s): Scott D.; Edmondson & Michael H.; Fisher & Dooseop; Kim & Malcolm; Maccoss & Emma R.; Parmee & Ann E.; Weber & Jinyou; Xu
    Assignee(s): Merck & Co., Inc.

    The present invention is directed to compounds which are inhibitors of the dipeptidyl peptidase-IV enzyme (“DP-IV inhibitors”) and which are useful in the treatment or prevention of diseases in which the dipeptidyl peptidase-IV enzyme is involved, such as diabetes and particularly type 2 diabetes. The invention is also directed to pharmaceutical compositions comprising these compounds and the use of these compounds and compositions in the prevention or treatment of such diseases in which the dipeptidyl peptidase-IV enzyme is involved.

    Patent expiration dates:

    • July 26, 2022
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 26, 2023
      ✓ 
      Pediatric exclusivity
  • Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
    Patent 7,125,873
    Issued: October 24, 2006
    Inventor(s): Edmondson; Scott D & Fisher; Michael H. & Kim; Dooseop & Maccoss; Malcolm & Parmee; Emma R. & Weber; Ann E & Xu; Jinyou
    Assignee(s): Merck & Co., Inc.

    The present invention is directed to compounds which are inhibitors of the dipeptidyl peptidase-IV enzyme (“DP-IV inhibitors”) and which are useful in the treatment or prevention of diseases in which the dipeptidyl peptidase-IV enzyme is involved, such as diabetes and particularly type 2 diabetes. The invention is also directed to pharmaceutical compositions comprising these compounds and the use of these compounds and compositions in the prevention or treatment of such diseases in which the dipeptidyl peptidase-IV enzyme is involved.

    Patent expiration dates:

    • July 26, 2022
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
    • July 26, 2022
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
    • July 26, 2022
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
    • July 26, 2022
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
    • January 26, 2023
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      Pediatric exclusivity
  • Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
    Patent 7,326,708
    Issued: February 5, 2008
    Inventor(s): Cypes; Stephen Howard & Chen; Alex Minhua & Ferlita; Russell R. & Hansen; Karl & Lee; Ivan & Vydra; Vicky K. & Wenslow, Jr.; Robert M.
    Assignee(s): Merck & Co., Inc.

    The dihydrogenphosphate salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro [1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine is a potent inhibitor of dipeptidyl peptidase-IV and is useful for the prevention and/or treatment of non-insulin dependent diabetes mellitus, also referred to as type 2 diabetes. The invention also relates to a crystalline monohydrate of the dihydrogenphosphate salt as well as a process for its preparation, pharmaceutical compositions containing this novel form and methods of use for the treatment of diabetes, obesity, and high blood pressure.

    Patent expiration dates:

    • November 24, 2026
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
      ✓ 
      Drug substance
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      Drug product
    • May 24, 2027
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      Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • August 12, 2022 - INFORMATION 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
    • February 12, 2023 - PEDIATRIC EXCLUSIVITY
    • December 4, 2023 - ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
    • June 4, 2024 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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