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Generic Gemtesa Availability

Last updated on May 11, 2022.

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

GEMTESA (vibegron - tablet;oral)

  • Manufacturer: UROVANT
    Approval date: December 23, 2020
    Strength(s): 75MG [RLD]

Has a generic version of Gemtesa been approved?

No. There is currently no therapeutically equivalent version of Gemtesa available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gemtesa. 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.

  • Hydroxymethyl pyrrolidines as β3 adrenergic receptor agonists
    Patent 8,247,415
    Issued: August 21, 2012
    Inventor(s): Berger; Richard & Chang; Lehua & Edmondson; Scott D. & Goble; Stephen D. & Ha; Sookhee Nicole & Kar; Nam Fung & Kopka; Ihor E. & Li; Bing & Morriello; Gregori J. & Moyes; Chris R. & Shen; Dong-Ming & Wang; Liping & Zhu; Cheng
    Assignee(s): Merck Sharp & Dohme Corp.

    The present invention provides compounds of Formula (I), pharmaceutical compositions thereof, and method of using the same in the treatment or prevention of diseases mediated by the activation of β3-adrenoceptor.

    Patent expiration dates:

    • December 1, 2030
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      Patent use: TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
      ✓ 
      Drug substance
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      Drug product
  • Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
    Patent 8,653,260
    Issued: February 18, 2014
    Assignee(s): Merck Sharp & Dohme Corp.

    The present invention provides compounds of Formula (I), pharmaceutical compositions thereof, and method of using the same in the treatment or prevention of diseases mediated by the activation of β3-adrenoceptor.

    Patent expiration dates:

    • April 2, 2029
      ✓ 
      Drug substance

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 23, 2025 - NEW CHEMICAL ENTITY

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.