Onglyza

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

ONGLYZA (saxagliptin hydrochloride - tablet; oral)

• 
  Manufacturer: BRISTOL MYERS SQUIBB
  
  Approval date: July 31, 2009
  
  Strength(s): EQ 2.5MG BASE, EQ 5MG BASE ^[RLD]

Has a generic version of Onglyza been approved?

No. There is currently no therapeutically equivalent version of Onglyza available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Onglyza. 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
    
    ✓ 
    Patent use: METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
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    Drug substance
    ✓ 
    Drug product
  
  



• 
  Coated tablet formulation and method
  Patent 7,951,400
  Issued: May 31, 2011
  Inventor(s): Desai; Divyakant S. & Li; Bing V.
  Assignee(s): Bristol-Myers Squibb Company
  A coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin or its HCl salt, 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:
  
  
  • November 30, 2028
    
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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:
  • December 16, 2013 - CHANGES ARE BASED ON RESULTS FROM STUDY CV181057
  
  
  • July 31, 2014 - NEW CHEMICAL ENTITY
  
  

See also...

• Onglyza Consumer Information (Drugs.com)
• Onglyza Consumer Information (Wolters Kluwer)
• Onglyza Consumer Information (Cerner Multum)
• Onglyza Advanced Consumer Information (Micromedex)
• Saxagliptin Consumer Information (Wolters Kluwer)
• Saxagliptin Consumer Information (Cerner Multum)
• Saxagliptin Advanced Consumer Information (Micromedex)