Generic Qtern Availability
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]
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 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.
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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 CompanySGLT2 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✓✓✓
- October 4, 2020✓✓✓
- October 4, 2020
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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 CompanyAn 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✓✓✓
- October 4, 2020✓✓✓
- October 4, 2020
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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 CompanyA 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✓
- October 4, 2020✓
- October 4, 2020
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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 CompanyThe 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✓
- 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 and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.
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
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 and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.
Patent expiration dates:
- 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
Assignee(s): Bristol-Myers Squibb CompanyThe 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✓✓
- June 20, 2027✓✓
- June 20, 2027
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Coated tablet formulation and method
Patent 8,628,799
Issued: January 14, 2014
Assignee(s): Bristol-Myers Squibb CompanyA 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✓
- July 13, 2025
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Pharmaceutical formulations containing an SGLT2 inhibitor
Patent 8,716,251
Issued: May 6, 2014
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 and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.
Patent expiration dates:
- March 21, 2028✓
- March 21, 2028
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Pharmaceutical formulations containing an SGLT2 inhibitor
Patent 9,198,925
Issued: December 1, 2015
Assignee(s): AstraZeneca ABPharmaceutical 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✓
- October 4, 2020✓
- October 4, 2020
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Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Patent RE44186
Issued: April 30, 2013
Assignee(s): Bristol-Myers Squibb CompanyDipeptidyl 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✓✓✓
- July 31, 2023✓✓✓
- July 31, 2023
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:
- January 8, 2019 - NEW CHEMICAL ENTITY
- April 5, 2019 - INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES
- February 27, 2020 - NEW COMBINATION
More about Qtern (dapagliflozin / saxagliptin)
- Qtern Side Effects
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- En Español
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- 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. |
