Generic Qtern Availability
Last updated on Nov 6, 2024.
Qtern is a brand name of dapagliflozin/saxagliptin, approved by the FDA in the following formulation(s):
QTERN (dapagliflozin; saxagliptin hydrochloride - tablet;oral)
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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.
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Patent 6,515,117
Patent expiration dates:
- October 4, 2025✓✓✓
- October 4, 2025
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Patent 7,919,598
Patent expiration dates:
- December 16, 2029✓
- December 16, 2029
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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 CompanyPharmaceutical 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
Patent expiration dates:
- March 21, 2028✓
- March 21, 2028
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Pharmaceutical formulations containing an SGLT2 inhibitor
Patent 8,361,972
Issued: January 29, 2013
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 CompanyPharmaceutical 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
Patent expiration dates:
- March 21, 2028✓
- March 21, 2028✓
- March 21, 2028✓
- March 21, 2028
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Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent 8,501,698
Issued: August 6, 2013
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 CompanyThe present invention relates to physical crystal structures of a compound of the formula I:
Patent expiration dates:
- June 20, 2027✓✓
- June 20, 2027✓✓
- June 20, 2027✓✓
- June 20, 2027
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Coated tablet formulation and method
Patent 8,628,799
Issued: January 14, 2014
Inventor(s): Desai Divyakant S. & Li Bing V.
Assignee(s): Bristol-Myers Squibb CompanyA coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin
Patent expiration dates:
- July 13, 2025✓
- July 13, 2025
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Pharmaceutical formulations containing an SGLT2 inhibitor
Patent 8,716,251
Issued: May 6, 2014
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 CompanyPharmaceutical 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
Patent expiration dates:
- March 21, 2028✓
- March 21, 2028
More about Qtern (dapagliflozin / saxagliptin)
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- During pregnancy
- FDA approval history
- Drug class: antidiabetic combinations
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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.
