Kombiglyze XR

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

KOMBIGLYZE XR (metformin hydrochloride; saxagliptin - tablet, extended release; oral)

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  Manufacturer: BRISTOL MYERS SQUIBB
  
  Approval date: November 5, 2010
  
  Strength(s): 1GM;2.5MG, 1GM;5MG ^[RLD], 500MG;5MG
  

Has a generic version of Kombiglyze XR been approved?

No. There is currently no therapeutically equivalent version of Kombiglyze XR available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kombiglyze 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: About generic drugs.

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.

• 
  Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
  Patent 6,395,767
  Issued: May 28, 2002
  Inventor(s): Jeffrey A.; Robl & Richard B.; Sulsky & David J.; Augeri & David R.; Magnin & Lawrence G.; Hamann & David A.; Betebenner
  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:
  
  
  • February 16, 2021
    
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    Patent use: ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE
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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:
  • July 31, 2014 - NEW CHEMICAL ENTITY
  
  

See also...

• Kombiglyze XR Consumer Information (Drugs.com)
• Kombiglyze XR Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Kombiglyze XR Consumer Information (Cerner Multum)
• Kombiglyze XR Advanced Consumer Information (Micromedex)
• Saxagliptin/Metformin Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Metformin and saxagliptin Consumer Information (Cerner Multum)
• Saxagliptin and metformin Advanced Consumer Information (Micromedex)