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Generic Jentadueto Availability

Last updated on Sep 8, 2021.

See also: Generic Jentadueto XR

Jentadueto is a brand name of linagliptin/metformin, approved by the FDA in the following formulation(s):

JENTADUETO (linagliptin; metformin hydrochloride - tablet;oral)

Has a generic version of Jentadueto been approved?

A generic version of Jentadueto has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Jentadueto and have been approved by the FDA:

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (linagliptin; metformin hydrochloride tablet;oral)

  • Manufacturer: SUNSHINE
    Approval date: August 30, 2021
    Strength(s): 2.5MG;1GM [AB], 2.5MG;500MG [AB], 2.5MG;850MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Jentadueto. 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.

  • DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
    Patent 10,022,379
    Issued: July 17, 2018
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.

    Patent expiration dates:

    • April 2, 2029
      ✓ 
      Patent use: USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
  • Patent 10,973,827

    Patent expiration dates:

    • April 2, 2029
      ✓ 
      Drug product
  • 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
    Patent 7,407,955
    Issued: August 5, 2008
    Inventor(s): Himmelsbach; Frank & Langkopf; Elke & Eckhardt; Matthias & Mark; Michael & Maier; Roland & Lotz; Ralf R. H. & Tadayyon; Mohammad
    Assignee(s): Boehringer Ingelheim Pharma GmbH & Co., KG

    The present invention relates to substituted xanthines of general formula wherein R1 to R3 are defined as in claims 1 to 16, the tautomers, the stereoisomers, the mixtures, the prodrugs thereof and the salts thereof which have valuable pharmacological properties, particularly an inhibiting effect on the activity of the enzyme dipeptidylpeptidase-IV (DPP-IV).

    Patent expiration dates:

    • May 2, 2025
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
    Patent 8,119,648
    Issued: February 21, 2012
    Inventor(s): Himmelsbach; Frank & Langkopf; Elke & Eckhardt; Matthias & Mark; Michael & Maier; Roland & Lotz; Ralf
    Assignee(s): Boehringer Ingelheim Pharma GmbH & Co. KG

    The present invention relates to substituted xanthines of general formula wherein R1 to R3 are as defined herein, the tautomers, the stereoisomers, the mixtures, the prodrugs thereof and the salts thereof which have valuable pharmacological properties, particularly an inhibiting effect on the activity of the enzyme dipeptidylpeptidase-IV (DPP-IV).

    Patent expiration dates:

    • August 12, 2023
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
  • 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
    Patent 8,178,541
    Issued: May 15, 2012
    Inventor(s): Himmelsbach; Frank & Langkopf; Elke & Eckhardt; Matthias & Mark; Michael & Maier; Roland & Lotz; Ralf & Tadayyon; Mohammad
    Assignee(s): Boehringer Ingelheim Pharma GmbH & Co. KG

    The present invention relates to substituted xanthines of general formula wherein R1 to R3 are as defined herein, the tautomers, the stereoisomers, the mixtures, the prodrugs thereof and the salts thereof which have valuable pharmacological properties, particularly an inhibiting effect on the activity of the enzyme dipeptidylpeptidase-IV (DPP-IV).

    Patent expiration dates:

    • August 12, 2023
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
      ✓ 
      Drug product
  • Uses of DPP-IV inhibitors
    Patent 8,673,927
    Issued: March 18, 2014
    Assignee(s): Boehringer Ingelheim International GmbH

    The specification describes the use of selected DPP IV inhibitors for the treatment of physiological functional disorders and for reducing the risk of the occurrence of such functional disorders in at-risk patient groups. In addition, the use of the above-mentioned DPP IV inhibitors in conjunction with other active substances is described, by means of which improved treatment outcomes can be achieved. These applications may be used to prepare corresponding medicaments.

    Patent expiration dates:

    • May 4, 2027
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
      ✓ 
      Sponsor has requested patent be delisted
  • Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
    Patent 8,846,695
    Issued: September 30, 2014
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for improving glycemic control in type 2 diabetes patients with inadequate glycemic control despite metformin therapy.

    Patent expiration dates:

    • June 4, 2030
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
      ✓ 
      Sponsor has requested patent be delisted
    • June 4, 2030
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
  • Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
    Patent 8,883,805
    Issued: November 11, 2014
    Assignee(s): Boehringer Ingelheim International GmbH

    The invention relates to an improved process for preparing enantiomerically pure 8-(3-aminopiperidin-1-yl)-xanthines.

    Patent expiration dates:

    • November 26, 2025
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      Drug product
  • DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
    Patent 9,155,705
    Issued: October 13, 2015
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.

    Patent expiration dates:

    • May 21, 2030
      ✓ 
      Drug product
  • DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
    Patent 9,415,016
    Issued: August 16, 2016
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.

    Patent expiration dates:

    • April 2, 2029
      ✓ 
      Drug product

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:

    • July 3, 2022 - INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
    • March 30, 2023 - ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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