Generic Kazano Availability
Last updated on May 7, 2025.
Kazano is a brand name of alogliptin/metformin, approved by the FDA in the following formulation(s):
KAZANO (alogliptin benzoate; metformin hydrochloride - tablet;oral)
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Manufacturer: TAKEDA PHARMS USA
Approval date: January 25, 2013
Strength(s): EQ 12.5MG BASE;1GM [RLD], EQ 12.5MG BASE;500MG [RLD]
Is there a generic version of Kazano available?
An Authorized Generic version of Kazano has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- alogliptin and metformin hydrochloride ORAL TABLET, FILM COATED 12.5; 500 mg/1; mg
Padagis Israel Pharmaceuticals Ltd
NDC Code: 458020169 - alogliptin and metformin hydrochloride ORAL TABLET, FILM COATED 12.5; 1000 mg/1; mg
Padagis Israel Pharmaceuticals Ltd
NDC Code: 458020211 - alogliptin and metformin hydrochloride ORAL TABLET, FILM COATED 12.5; 1000 mg/1; mg
A-S Medication Solutions
NDC Code: 500905993
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kazano. 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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Dipeptidyl peptidase inhibitors
Patent 7,807,689
Issued: October 5, 2010
Inventor(s): Zhang; Zhiyuan et al.
Assignee(s): Takeda Pharmaceutical Company Limited (Osaka, JP)The present invention provides a compound of the formula: ##STR00001## or stereoisomers or pharmaceutically acceptable salts thereof, pharmaceutical compositions thereof, articles of manufacture comprising the same, and methods of using the same.
Patent expiration dates:
- June 27, 2028✓✓✓
- June 27, 2028
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Dipeptidyl peptidase inhibitors
Patent 8,173,663
Issued: May 8, 2012
Inventor(s): Feng Jun & Gwaltney Stephen L. & Stafford Jeffrey A. & Zhang Zhiyuan & Elder Bruce J. & Isbester Paul K. & Palmer Grant J. & Salsbury Jonathon S. & Ulysse Luckner G.
Assignee(s): Takeda Pharmaceutical Company LimitedCompounds, pharmaceuticals, kits and methods are provided for use with DPP-IV and other S9 proteases that comprise a compound comprising:
Patent expiration dates:
- March 15, 2025✓
- March 15, 2025
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Dipeptidyl peptidase inhibitors
Patent 8,288,539
Issued: October 16, 2012
Inventor(s): Feng Jun & Gwaltney Stephen L. & Stafford Jeffrey A. & Zhang Zhiyuan & Elder Bruce J. & Isbester Paul K. & Palmer Grant J. & Salsbury Jonathon S. & Ulysse Luckner G.
Assignee(s): Takeda Pharmaceutical Company LimitedCompounds, pharmaceuticals, kits and methods are provided for use with DPP-IV and other S9 proteases that comprise a compound comprising:
Patent expiration dates:
- June 24, 2025✓
- June 24, 2025
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Solid preparation comprising alogliptin and metformin hydrochloride
Patent 8,900,638
Issued: December 2, 2014
Inventor(s): Yamamoto Kazumichi & Koyama Hiroyoshi
Assignee(s): Takeda Pharmaceutical Company LimitedThe present invention provides a solid preparation containing compound (I) [compound (I) is as defined in the specification] or a salt thereof, and metformin hydrochloride, which is useful as a therapeutic drug for diabetes and the like, and superior in the preservation stability. A solid preparation having a first part and a second part: a first part: a part containing compound (I) or a salt thereof and substantially free of metformin hydrochloride a second part: a part containing metformin hydrochloride and substantially free of compound (I) and a salt thereof.
Patent expiration dates:
- May 24, 2029✓
- May 24, 2029
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 27, 2026 - REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST
More about Kazano (alogliptin / metformin)
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- During pregnancy
- FDA approval history
- Drug class: antidiabetic combinations
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Glossary
Term | Definition |
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.