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Generic Jardiance Availability

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

JARDIANCE (empagliflozin - tablet;oral)

Has a generic version of Jardiance been approved?

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

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

  • 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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      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

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:
    • June 26, 2018 - UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND ACTIVE-CONTROLLED STUDY COMPARING EMPAGLIFLOZIN TO GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES AND INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN TREATMENT
    • June 26, 2018 - UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EMPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON A MULTIPLE DAILY INJECTION INSULIN REGIMEN ALONE OR WITH METFORMIN
    • March 18, 2019 - INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
    • 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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