Generic Kombiglyze XR Availability
KOMBIGLYZE XR (metformin hydrochloride; saxagliptin hydrochloride - tablet, extended release;oral)
Manufacturer: ASTRAZENECA AB
Approval date: November 5, 2010
Strength(s): 1GM;EQ 2.5MG BASE, 1GM;EQ 5MG BASE [RLD], 500MG;EQ 5MG BASE
Has a generic version of Kombiglyze XR been approved?
No. There is currently no therapeutically equivalent version of Kombiglyze XR available in the United States.
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.
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.
Coated tablet formulation and method
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✓
- July 13, 2025
Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
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✓✓✓
- July 31, 2023
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 -
- May 24, 2016 - ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED WITH SAXAGLIPTIN IN COMBINATION WITH METFORMIN AND A SULFONYLUREA ADDED TO THE LABELING
More about Kombiglyze XR (metformin / saxagliptin)
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|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.|