Skip to main content

Generic Synjardy Availability

Last updated on Nov 8, 2022.

See also: Generic Synjardy XR

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

SYNJARDY (empagliflozin; metformin hydrochloride - tablet;oral)

Has a generic version of Synjardy been approved?

A generic version of Synjardy 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 Synjardy and have been approved by the FDA:

EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (empagliflozin; metformin hydrochloride tablet;oral)

  • Manufacturer: ZYDUS PHARMS
    Approval date: July 7, 2022
    Strength(s): 5MG;1GM [AB], 5MG;500MG [AB], 12.5MG;1GM [AB], 12.5MG;500MG [AB]

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

  • Pharmaceutical composition, methods for treating and uses thereof
    Patent 10,258,637
    Issued: April 16, 2019
    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:

    • April 3, 2034
      ✓ 
      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
  • Patent 10,610,489

    Patent expiration dates:

    • September 30, 2030
      ✓ 
      Drug product
  • Patent 11,090,323

    Patent expiration dates:

    • April 3, 2034
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
  • 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:

    • August 1, 2028
      ✓ 
      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-J&#xfc;rgen & 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
      ✓ 
      Drug substance
      ✓ 
      Drug product

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.