Generic Brynovin Availability
Last updated on May 7, 2025.
Brynovin is a brand name of sitagliptin, approved by the FDA in the following formulation(s):
BRYNOVIN (sitagliptin hydrochloride - solution;oral)
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Manufacturer: AZURITY
Approval date: January 16, 2025
Strength(s): EQ 25MG BASE/ML [RLD]
Is there a generic version of Brynovin available?
No. There is currently no therapeutically equivalent version of Brynovin available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Brynovin. 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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Oral gliptin compositions and method for preparation thereof
Patent 11,944,621
Issued: April 2, 2024
Inventor(s): Psarrakis; Ioannis et al.
Assignee(s): AUTHENDA PHARMACEUTICALS AG (Schindellegi, CH)Described is an aqueous liquid oral gliptin composition comprising a gliptin or a pharmaceutically acceptable salt or ester thereof, and an artificial non-sugar alcohol sweetening agent, the solution having a sugar alcohol content of less than 25 w/v %. The composition has an improved taste and stability as compared to known compositions. Also described is a method comprising the steps of heating 80-95 v/v % of the water to 40-65° C., admixing the antioxidant, and, if present, the chelating agent and buffering agent, optionally, cooling down to 25-35° C., admixing sweetener, and, if present, preservative agent, and optionally pH adjusting agent or a portion of the pH adjusting agent, admixing the gliptin, if necessary, adjust the pH to the envisaged value by addition of a pH adjusting agent, admix the thickening agent, optionally in the form of a solution of the thickening agent in a co-solvent, homogenising the obtained mixture, admixing, if present, the wetting agent, if necessary, adjust the final volume by adding from the rest of the water, optionally filter through a 10 μm sieve, and filling in an appropriate container.
Patent expiration dates:
- October 23, 2040✓
- October 23, 2040
More about Brynovin (sitagliptin)
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- During pregnancy
- Drug class: dipeptidyl peptidase 4 inhibitors
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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
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