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Generic Qtern Availability

Last updated on Sep 8, 2021.

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

QTERN (dapagliflozin; saxagliptin hydrochloride - tablet;oral)

  • Manufacturer: ASTRAZENECA AB
    Approval date: February 27, 2017
    Strength(s): 10MG;EQ 5MG BASE [RLD]
  • Manufacturer: ASTRAZENECA AB
    Approval date: May 2, 2019
    Strength(s): 5MG;EQ 5MG BASE [RLD]

Has a generic version of Qtern been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Qtern. 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
  • 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
  • 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: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
    • March 21, 2028
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      Patent use: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
  • 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
    • June 20, 2027
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      Patent use: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
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      Drug product
    • June 20, 2027
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      Patent use: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
      ✓ 
      Drug product
  • Coated tablet formulation and method
    Patent 8,628,799
    Issued: January 14, 2014
    Assignee(s): Bristol-Myers Squibb Company

    A coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin which is subject to intra-molecular cyclization, which formulation includes a tablet core containing one or more fillers, and other conventional excipients, which tablet core includes a coating thereon which may include two or more layers, at least one layer of which is an inner seal coat layer which is formed of one or more coating polymers, a second layer of which is formed of medicament which is the DPP4-inhibitor and one or more coating polymers, and an optional, but preferable third outer protective layer which is formed of one or more coating polymers. A method for forming the coated tablet is also provided.

    Patent expiration dates:

    • July 13, 2025
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      Drug product
  • 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
  • Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
    Patent RE44186
    Issued: April 30, 2013
    Assignee(s): Bristol-Myers Squibb Company

    Dipeptidyl peptidase IV (DP 4) inhibiting compounds are provided having the formula where x is 0 or 1 and y is 0 or 1 (provided that x=1 when y=0 and x=0 when y=1); n is 0 or 1; X is H or CN; and wherein R1, R2, R3 and R4 are as described herein. A method is also provided for treating diabetes and related diseases, especially Type II diabetes, and other diseases as set out herein, employing such DP 4 inhibitor *or a combination of such DP 4 inhibitor and one or more of another antidiabetic agent such as metformin, glyburide, troglitazone, pioglitazone, rosiglitazone and/or insulin and/or one or more of a hypolipidemic agent and/or anti-obesity agent and/or other therapeutic agent.

    Patent expiration dates:

    • July 31, 2023
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      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
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      Drug substance
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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:

    • May 2, 2022 - NEW STRENGTH
    • May 2, 2022 - EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

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.

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