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Generic Brexafemme Availability

Last updated on Nov 8, 2022.

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

BREXAFEMME (ibrexafungerp citrate - tablet;oral)

  • Manufacturer: SCYNEXIS
    Approval date: June 1, 2021
    Strength(s): EQ 150MG BASE [RLD]

Has a generic version of Brexafemme been approved?

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

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

  • Salts and polymorphs of SCY-078
    Patent 10,174,074
    Issued: January 8, 2019
    Assignee(s): SCYNEXIS, INC.

    SCY-078 is a glucan synthase inhibitor with antimicrobial activity. Novel salts and polymorph forms of SCY-078 are disclosed herein. The disclosure also relates to pharmaceutical compositions, methods of use, and methods of preparing the novel salts and polymorphs of SCY-078.

    Patent expiration dates:

    • January 19, 2035
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  • Patent 10,370,406

    Patent expiration dates:

    • January 19, 2035
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      Patent use: TREATMENT OF ADULT AND POST-MENARCHAL PEDIATRIC FEMALES WITH VULVOVAGINAL CANDIDIASIS (VVC)
  • Patent 10,927,142

    Patent expiration dates:

    • January 19, 2035
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  • Antifungal agents
    Patent 8,188,085
    Issued: May 29, 2012
    Inventor(s): Greenlee; Mark L. & Wilkening; Robert & Apgar; James & Sperbeck; Donald & Wildonger; Kenneth J. & Meng; Dongfang & Parker, Jr.; Dann L. & Pacofsky; Gregory J. & Heasley; Brian H. & Mamai; Ahmed & Nelson; Kingsley
    Assignee(s): Merck Sharp & Dohme Corp. Seynexis, Inc.

    Novel derivatives of enfumafungin are disclosed herein, along with their pharmaceutically acceptable salts, hydrates and prodrugs. Also disclosed are compositions comprising such compounds, methods of preparing such compounds and methods of using such compounds as antifungal agents and/or inhibitors of (1,3)-β-D-glucan synthase. The disclosed compounds, their pharmaceutically acceptable salts, hydrates and prodrugs, as well as compositions comprising such compounds, salts, hydrates and prodrugs, are useful for treating and/or preventing fungal infections and associated diseases and conditions.

    Patent expiration dates:

    • August 28, 2030
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      Patent use: TREATMENT OF ADULT AND POST-MENARCHAL PEDIATRIC FEMALES WITH VULVOVAGINAL CANDIDIASIS (VVC)
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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:

    • June 1, 2026 - NEW CHEMICAL ENTITY
    • June 1, 2031 - GENERATING ANTIBIOTIC INCENTIVES NOW

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.