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Generic Glyxambi Availability

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

GLYXAMBI (empagliflozin; linagliptin - tablet;oral)

Has a generic version of Glyxambi been approved?

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

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

  • Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals
    Patent 6,303,661
    Issued: October 16, 2001
    Inventor(s): Demuth; Hans-Ulrich & Rosche; Fred & Schmidt; Joem & Pauly; Robert P. & McIntosh; Christopher H. S. & Pederson; Ray A.
    Assignee(s): Probiodrug
    Novel therapeutic regimens are provided which comprise the administration of therapeutically effective amounts of an inhibitor to dipeptidyl peptidase (DP-IV) or enzymes of similar activity whereby their ability to degrade the incretins, GLP-1 and GIP, is reduced. As a result hyperglycemia, such as that accompanying food intake may be reduced due to improved insulin release. A preferred therapeutic regimen amongst a number of routes of administration and inhibitors that may be used comprises the oral administration of isoleucyl thiazolidine.
    Patent expiration dates:
    • April 24, 2017
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
  • 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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
  • 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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
  • 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
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      Drug substance
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      Drug product
  • 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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
  • Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
    Patent 7,579,449
    Issued: August 25, 2009
    Inventor(s): Eckhardt; Matthias & Eickelmann; Peter & Himmelsbach; Frank & Barsoumian; Edward Leon & Thomas; Leo
    Assignee(s): Boehringer Ingelheim International GmbH
    Glucopyranosyl-substituted benzene derivatives of general formula I where the groups R1 to R6 as well as R7a, R7b, R7c are defined herein and the tautomers, the stereoisomers thereof, the mixtures thereof and the salts thereof. The compounds according to the invention are suitable for the treatment of metabolic disorders.
    Patent expiration dates:
    • November 5, 2025
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      Drug substance
  • Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
    Patent 7,713,938
    Issued: May 11, 2010
    Inventor(s): Himmelsbach; Frank & Schmid; Sandra & Schuehle; Martin & Martin; Hans-Jürgen & Eckhardt; Matthias
    Assignee(s): Boehringer Ingelheim International GmbH
    The invention relates to a crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S) -tetrahydrofuran-3-yloxy)-benzyl]-benzene, to a method for the preparation thereof, as well as to the use thereof for preparing medicaments.
    Patent expiration dates:
    • April 15, 2027
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      Drug substance
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  • 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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
  • 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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
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      Drug product
    • August 12, 2023
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
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      Drug product
  • Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
    Patent 8,551,957
    Issued: October 8, 2013
    Assignee(s): Boehringer Ingelheim International GmbH
    The invention relates to a pharmaceutical composition according to the claim 1 comprising a glucopyranosyl-substituted benzene derivative in combination with a DPP IV inhibitor which is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.
    Patent expiration dates:
    • October 14, 2029
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
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      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 EMPAGLIFLOZIN AND METFORMIN
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      Drug product
  • 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
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND 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
  • Uses of DPP IV inhibitors
    Patent 9,173,859
    Issued: November 3, 2015
    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 EMPAGLIFLOZIN
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      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:
    • May 2, 2016 - NEW CHEMICAL ENTITY
    • January 30, 2018 - NEW COMBINATION
    • August 1, 2019 - NEW CHEMICAL ENTITY

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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