Generic Nesina Availability
Last updated on Sep 11, 2024.
Nesina is a brand name of alogliptin, approved by the FDA in the following formulation(s):
NESINA (alogliptin benzoate - tablet;oral)
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Manufacturer: TAKEDA PHARMS USA
Approval date: January 25, 2013
Strength(s): EQ 6.25MG BASE [RLD], EQ 12.5MG BASE [RLD], EQ 25MG BASE [RLD]
Has a generic version of Nesina been approved?
An Authorized Generic version of Nesina 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 ORAL TABLET, FILM COATED 6.25 mg
Padagis Israel Pharmaceuticals Ltd
NDC Code: 458020087 - Alogliptin ORAL TABLET, FILM COATED 12.5 mg
Padagis Israel Pharmaceuticals Ltd
NDC Code: 458020103 - Alogliptin ORAL TABLET, FILM COATED 25 mg
Padagis Israel Pharmaceuticals Ltd
NDC Code: 458020150 - Alogliptin ORAL TABLET, FILM COATED 25 mg
A-S Medication Solutions
NDC Code: 500905574 - Alogliptin ORAL TABLET, FILM COATED 25 mg
REMEDYREPACK INC.
NDC Code: 705183976 - Alogliptin ORAL TABLET, FILM COATED 25 mg
Aphena Pharma Solutions - Tennessee, LLC
NDC Code: 716100300 - Alogliptin ORAL TABLET, FILM COATED 12.5 mg
Aphena Pharma Solutions - Tennessee, LLC
NDC Code: 716100661
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nesina. 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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Patent 7,807,689
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:
- December 2, 2025✓
- December 2, 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:
- March 15, 2025✓
- March 15, 2025
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Tablet preparation without causing a tableting trouble
Patent 8,697,125
Issued: April 15, 2014
Inventor(s): Ono Akihiko & Marunaka Shigeyuki & Fukuta Makoto
Assignee(s): Takeda Pharmaceutical Company LimitedThe present invention provides a tablet without causing a tableting trouble, which is superior in the tablet formability, dissolution property of pharmaceutically active ingredient, and the like.
Patent expiration dates:
- June 16, 2029✓
- June 16, 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 Nesina (alogliptin)
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- During pregnancy
- FDA approval history
- Drug class: dipeptidyl peptidase 4 inhibitors
- Breastfeeding
- En español
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
