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Generic Januvia Availability

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 FAQs.

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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
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  • Method of regulating glucose metabolism, and reagents related thereto
    Patent 6,890,898
    Issued: May 10, 2005
    Inventor(s): Bachovchin; William W. & Plaut; Andrew G. & Drucker; Daniel
    Assignee(s): Trustees of Tufts College 1149336 Ontario Inc. New England Medical Center Hospitals, Inc.
    The present invention provides methods and compositions for modification and regulation of glucose and lipid metabolism, generally to reduce insulin resistance, hyperglycemia, hyperinsulinemia, obesity, hyperlipidemia, hyperlipoprotein-emia (such as chylomicrons, VLDL and LDL), and to regulate body fat and more generally lipid stores, and, more generally, for the improvement of metabolism disorders, especially those associated with diabetes, obesity and/or atherosclerosis.
    Patent expiration dates:
    • February 2, 2019
      ✓ 
      Patent use: IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR A PPAR-GAMMA AGONIST AND/OR SULFONYLUREA AND/OR INSULIN
  • Method of regulating glucose metabolism, and reagents related thereto
    Patent 7,078,381
    Issued: July 18, 2006
    Inventor(s): Bachovchin; William W. & Plaut; Andrew G. & Drucker; Daniel
    Assignee(s): Trustees of Tufts College
    The present invention provides methods and compositions for modifying glucose metabolism and treating Type II diabetes in an animal, along with modifying metabolism of a peptide hormone in an animal. Compositions disclosed herein comprise one or more peptides and/or peptide analogs which include a functional group that reacts with an active site residue of a protease.
    Patent expiration dates:
    • February 2, 2019
      ✓ 
      Patent use: IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR A PPAR-GAMMA AGONIST AND/OR SULFONYLUREA AND/OR INSULIN
  • 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-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
    • 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 INSULIN
    • July 26, 2022
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
  • 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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
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  • Method of regulating glucose metabolism, and reagents related thereto
    Patent 7,459,428
    Issued: December 2, 2008
    Inventor(s): Bachovchin; William W. & Plaut; Andrew G. & Drucker; Daniel
    Assignee(s): Trustees of Tufts College New England Medical Center Hospitals, Inc. 1149336 Ontario, Inc.
    One aspect of the present invention relates to a method for treating Type II diabetes in an animal, comprising conjointly administering to the animal metformin and an inhibitor of dipeptidylpeptidase IV or a pharmaceutically acceptable salt thereof in an amount sufficient to treat Type II diabetes of the animal.
    Patent expiration dates:
    • February 2, 2019
      ✓ 
      Patent use: IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN.
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Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.

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