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Generic Xigduo XR Availability

Last updated on May 11, 2021.

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

XIGDUO XR (dapagliflozin; metformin hydrochloride - tablet, extended release;oral)

  • Manufacturer: ASTRAZENECA AB
    Approval date: October 29, 2014
    Strength(s): 5MG;1GM [RLD], 5MG;500MG [RLD], 10MG;1GM [RLD], 10MG;500MG [RLD]
  • Manufacturer: ASTRAZENECA AB
    Approval date: July 28, 2017
    Strength(s): 2.5MG;1GM [RLD]

Has a generic version of Xigduo XR been approved?

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

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

  • C-aryl glucoside SGLT2 inhibitors and method
    Patent 6,515,117
    Issued: February 4, 2003
    Inventor(s): Bruce; Ellsworth & William N.; Washburn & Philip M.; Sher & Gang; Wu & Wei; Meng
    Assignee(s): Bristol-Myers Squibb Company

    An SGLT2 inhibiting compound is provided having the formula A method is also provided for treating diabetes and related diseases employing an SGLT2 inhibiting amount of the above compound alone or in combination with another antidiabetic agent or other therapeutic agent.

    Patent expiration dates:

    • October 4, 2025
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
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      Drug substance
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      Drug product
  • Crystal structures of SGLT2 inhibitors and processes for preparing same
    Patent 7,919,598
    Issued: April 5, 2011
    Inventor(s): Gougoutas; Jack Z. & Lobinger; Hildegard & Ramakrishnan; Srividya & Deshpande; Prashant P. & Bien; Jeffrey T. & Lai; Chiajen & Wang; Chenchi & Riebel; Peter & Grosso; John Anthony & Nirschl; Alexandra A. & Singh; Janak & DiMarco; John D.
    Assignee(s): Bristol-Myers Squibb Company

    The present invention relates to physical crystal structures of a compound of the formula I: wherein R1, R2, R2a, R3 and R4 are as defined herein, especially pharmaceutical compositions containing structures of compound I or II, processes for preparing same, intermediates used in preparing same, and methods of treating diseases such as diabetes using such structures.

    Patent expiration dates:

    • December 16, 2029
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      Drug substance
  • Crystal structures of SGLT2 inhibitors and processes for preparing same
    Patent 8,501,698
    Issued: August 6, 2013
    Assignee(s): Bristol-Myers Squibb Company

    The present invention relates to physical crystal structures of a compound of the formula I: wherein R1, R2, R2a, R3 and R4 are as defined herein, especially pharmaceutical compositions containing structures of compound I or II, processes for preparing same, intermediates used in preparing same, and methods of treating diseases such as diabetes using such structures.

    Patent expiration dates:

    • June 20, 2027
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
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      Drug product
  • Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
    Patent 8,685,934
    Issued: April 1, 2014
    Assignee(s): Bristol-Myers Squibb Company

    The invention provides methods for treating a patient having type 2 diabetes who has failed on previous regimens of one or more oral and/or injectable anti-diabetic agents, which include the step of administering a therapeutically effective amount of an SGLT2 inhibitor alone or in combination with another anti-diabetic agent and/or other therapeutic agent to such patient. A pharmaceutical composition containing dapagliflozin or dapagliflozin-S-propylene glycol solvate and one or more diabetic agents and/or other therapeutic agents for use in the methods of the invention is also provided.

    Patent expiration dates:

    • May 26, 2030
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
  • Bilayer tablet formulations
    Patent 9,616,028
    Issued: April 11, 2017
    Assignee(s): AstraZeneca AB AstraZeneca UK Limited

    The present invention relates to bilayer tablet formulations comprising metformin extended release (XR) or reduced mass metformin XR formulation as the first layer, an SGLT2 inhibitor formulation as the second layer, and optionally a film coating. The present invention provides methods of preparing the bilayer tablet formulations and methods of treating diseases or disorders associated with SGLT2 activity employing the bilayer tablet formulations.

    Patent expiration dates:

    • November 12, 2030
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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:

    • October 18, 2022 - TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS

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.

Further information

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