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Generic Farxiga Availability

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

FARXIGA (dapagliflozin - tablet;oral)

  • Manufacturer: ASTRAZENECA AB
    Approval date: January 8, 2014
    Strength(s): 5MG [RLD], 10MG [RLD]

Has a generic version of Farxiga been approved?

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

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

  • C-aryl glucoside SGLT2 inhibitors and method
    Patent 6,414,126
    Issued: July 2, 2002
    Inventor(s): Bruce; Ellsworth & William N.; Washburn & Philip M.; Sher & Gang; Wu & Wei; Meng
    Assignee(s): Bristol-Myers Squibb Company

    SGLT2 inhibiting compounds are provided having the formula where R1, R2, and R2a are independently hydrogen, OH, OR5, lower alkyl, CF3, OCHF2, OCF3, SR5i or halogen, or two of R1, R2 and R2a together with the carbons to which they are attached can form an annelated five, six or seven membered carbocycle or heterocycle; R3 and R4 are independently hydrogen, OH, OR5a, OAryl, OCH2Aryl, lower alkyl, cycloalkyl, CF3, —OCHF2, —OCF3, halogen, —CN, —CO2R5b, —CO2H, —COR6b, —CH(OH)R6c, —CH(OR5h)R6d, —CONR6R6a, —NHCOR5c, —NHSO2R5d, —NHSO2Aryl, Aryl, —SR5e, —SOR5f, —SO2R5g, —SO2Aryl, or a five, six or seven membered heterocycle, or R3 and R4 together with the carbons to which they are attached form an annelated five, six or seven membered carbocycle or heterocycle; R5, R5a, R5b, R5c, R5d, R5e, R5f, R5g, R5h and R5i are independently lower alkyl; R6, R6a, R6b, R6c and R6d are independently hydrogen, alkyl,aryl, alkylaryl or cycloalkyl, or R6 and R6a together with the nitrogen to which they are attached form an annelated five, six or seven membered heterocycle; A is O, S, NH, or (CH2)n where n is 0-3. 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, 2020
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
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      Drug substance
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      Drug product
    • October 4, 2020
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
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      Drug substance
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      Drug product
  • 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, 2020
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
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      Drug substance
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      Drug product
    • October 4, 2020
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
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      Drug substance
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      Drug product
  • C-aryl glucoside SGLT2 inhibitors and method
    Patent 6,936,590
    Issued: August 30, 2005
    Inventor(s): Washburn; William N. & Ellsworth; Bruce & Meng; Wei & Wu; Gang & Sher; Philip M.
    Assignee(s): Bristol Myers Squibb Company

    A method is provided for treating diabetes and related diseases employing an SGLT2 inhibiting amount of a compound of the formula alone or in combination with one or more other antidiabetic agent(s) or other therapeutic agent(s).

    Patent expiration dates:

    • October 4, 2020
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
  • Polymer-based sustained release device
    Patent 7,456,254
    Issued: November 25, 2008
    Inventor(s): Wright; Steven G. & Christenson; Troy & Yeah; Thean Y. & Rickey; Michael E. & Hotz; Joyce M. & Kumar; Rajesh & Costantino; Henry R.
    Assignee(s): Alkermes, Inc.

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • June 30, 2025
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
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      Drug product
  • Pharmaceutical formulations containing an SGLT2 inhibitor
    Patent 7,851,502
    Issued: December 14, 2010
    Inventor(s): Bindra; Dilbir S. & Dali; Mandar V. & Parab; Prakash V. & Patel; Jatin M. & Tao; Li & Tejwani; Ravindra W. & Vatsaraj; Nipa & Wu; Yongmei
    Assignee(s): Bristol-Myers Squibb Company

    Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

    Patent expiration dates:

    • August 19, 2028
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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
  • Pharmaceutical formulations containing an SGLT2 inhibitor
    Patent 8,221,786
    Issued: July 17, 2012
    Inventor(s): Bindra; Dilbir S. & Dali; Mandar V. & Parab; Prakash V. & Patel; Jatin M. & Tao; Li & Tejwani; Ravindra W. & Vatsaraj; Nipa & Wu; Yongmei
    Assignee(s): Bristol-Myers Squibb Company

    Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

    Patent expiration dates:

    • March 21, 2028
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      Drug product
  • Methods for treating diabetes and reducing body weight
    Patent 8,329,648
    Issued: December 11, 2012
    Inventor(s): Fineman; Mark & MacConell; Leigh & Taylor; Kristin
    Assignee(s): Amylin Pharmaceuticals, LLC

    Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.

    Patent expiration dates:

    • August 18, 2026
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      Patent use: REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
    • August 18, 2026
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      Patent use: REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
    • August 18, 2026
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
  • Pharmaceutical formulations containing an SGLT2 inhibitor
    Patent 8,361,972
    Issued: January 29, 2013
    Assignee(s): Bristol Myers-Squibb Company

    Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

    Patent expiration dates:

    • March 21, 2028
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
    • March 21, 2028
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
  • Polymer-based sustained release device
    Patent 8,431,685
    Issued: April 30, 2013
    Assignee(s): Alkermes Pharma Ireland Limited

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 13, 2025
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
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      Drug product
  • Polymer-based sustained release device
    Patent 8,461,105
    Issued: June 11, 2013
    Assignee(s): Alkermes Pharma Ireland Limited

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 13, 2025
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
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      Drug product
  • 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
  • Pharmaceutical formulations containing an SGLT2 inhibitor
    Patent 8,716,251
    Issued: May 6, 2014
    Assignee(s): Bristol-Myers Squibb Company

    Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

    Patent expiration dates:

    • March 21, 2028
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      Drug product
  • Ampoule comprising an ampoule holder
    Patent 8,721,615
    Issued: May 13, 2014
    Assignee(s): TecPharma Licensing AG

    An ampoule including a casing, a facing side and a seal, wherein the casing has an outer diameter and the seal extends radially beyond the outer diameter and seals the facing side.

    Patent expiration dates:

    • January 18, 2030
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      Drug product
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      Sponsor has requested patent be delisted
  • Method for treating diabetes
    Patent 8,906,851
    Issued: December 9, 2014
    Assignee(s): Amylin Pharmaceuticals, LLC AstraZeneca Pharmaceuticals LP

    Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.

    Patent expiration dates:

    • August 18, 2026
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
  • Pharmaceutical formulations containing an SGLT2 inhibitor
    Patent 9,198,925
    Issued: December 1, 2015
    Assignee(s): AstraZeneca AB

    Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

    Patent expiration dates:

    • October 4, 2020
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
    • October 4, 2020
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
  • Polymer-based sustained release device
    Patent 9,238,076
    Issued: January 19, 2016
    Assignee(s): Alkermes Pharma Ireland Limited Amylin Pharmaceuticals, LLC

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 15, 2024
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
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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:

    • March 11, 2018 - INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN 10MG ONCE DAILY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND SULFONYLUREA
    • January 8, 2019 - NEW CHEMICAL ENTITY
    • October 20, 2020 - INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND EXENATIDE EXTENDED RELEASE

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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