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Generic Synjardy XR Availability

See also: Generic Synjardy

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

SYNJARDY XR (empagliflozin; metformin hydrochloride - tablet, extended release;oral)

Has a generic version of Synjardy XR been approved?

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

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

  • Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
    Patent 6,488,962
    Issued: December 3, 2002
    Inventor(s): Bret; Berner & Jenny; Louie-Helm
    Assignee(s): DepoMed, Inc.

    The retention of oral drug dosage forms in the stomach is improved by using swellable dosage forms that are shaped in a manner that will prevent them from inadvertently passing through the pylorus as a result of being in a particular orientation. The planar projection of the shape is one that has two orthogonal axes of different lengths, the longer being short enough to permit easy swallowing prior to swelling while the shorter is long enough within one-half hour of swelling to prevent passage through the pylorus.

    Patent expiration dates:

    • June 20, 2020
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      Drug product
  • 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, methods for treating and uses thereof
    Patent 9,949,998
    Issued: April 24, 2018
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).

    Patent expiration dates:

    • June 11, 2034
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN

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:

    • August 1, 2019 - NEW CHEMICAL ENTITY
    • December 2, 2019 - TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE

Further information

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

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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