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Generic Janumet XR Availability

See also: Generic Janumet

Janumet XR is a brand name of metformin/sitagliptin, approved by the FDA in the following formulation(s):

JANUMET XR (metformin hydrochloride; sitagliptin phosphate - tablet, extended release;oral)

  • Manufacturer: MERCK SHARP DOHME
    Approval date: February 2, 2012
    Strength(s): 1GM;EQ 50MG BASE, 1GM;EQ 100MG BASE [RLD], 500MG;EQ 50MG BASE

Has a generic version of Janumet XR been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Janumet XR. 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: About generic drugs.

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.

  • Extending the duration of drug release within the stomach during the fed mode
    Patent 6,340,475
    Issued: January 22, 2002
    Inventor(s): John W.; Shell & Jenny; Louie-Helm & Micheline; Markey
    Assignee(s): DepoMed, Inc.
    Drugs are formulated as unit oral dosage forms by incorporating them into polymeric matrices comprised of hydrophilic polymers that swell upon imbibition of water to a size that is large enough to promote retention of the dosage form in the stomach during the fed mode. The oral formulation is designed for gastric retention and controlled delivery of an incorporated drug into the gastric cavity, and thus administered, the drug is released from the matrix into the gastric fluid by solution diffusion. The swollen polymeric matrix, having achieved sufficient size, remains in the gastric cavity for several hours if administered while the patient is in the fed mode, and remains intact long enough for substantially all of the drug to be released before substantial dissolution of the matrix occurs. The swelling matrix lowers the accessibility of the gastric fluid to the drug and thereby reduces the drug release rate. This process, together with diffusion retardation by selection of specific polymers, polymer molecular weights, and other variables, results in a sustained and controlled delivery rate of the drug to the gastric cavity.
    Patent expiration dates:
    • September 19, 2016
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      Drug product
  • Extending the duration of drug release within the stomach during the fed mode
    Patent 6,635,280
    Issued: October 21, 2003
    Inventor(s): John W.; Shell & Jenny; Louie-Helm & Micheline; Markey
    Assignee(s): DepoMed, Inc.
    Drugs are formulated as unit oral dosage forms by incorporating them into polymeric matrices comprised of hydrophilic polymers that swell upon imbibition of water to a size that is large enough to promote retention of the dosage form in the stomach during the fed mode. The oral formulation is designed for gastric retention and controlled delivery of an incorporated drug into the gastric cavity, and thus administered, the drug is released from the matrix into the gastric fluid by solution diffusion. The swollen polymeric matrix, having achieved sufficient size, remains in the gastric cavity for several hours if administered while the patient is in the fed mode, and remains intact long enough for substantially all of the drug to be released before substantial dissolution of the matrix occurs. The swelling matrix lowers the accessibility of the gastric fluid to the drug and thereby reduces the drug release rate. This process, together with diffusion retardation by selection of specific polymers, polymer molecular weights, and other variables, results in a sustained and controlled delivery rate of the drug to the gastric cavity.
    Patent expiration dates:
    • September 19, 2016
      ✓ 
      Drug product
  • 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 IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
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      Drug substance
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      Drug product
  • 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 IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
      ✓ 
      Drug product
  • 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:
    • April 11, 2026
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
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      Drug substance
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      Drug product

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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