Skip to main content

Generic Winlevi Availability

Last updated on Nov 8, 2022.

Winlevi is a brand name of clascoterone topical, approved by the FDA in the following formulation(s):

WINLEVI (clascoterone - cream;topical)

  • Manufacturer: SUN PHARM
    Approval date: August 26, 2020
    Strength(s): 1% [RLD]

Has a generic version of Winlevi been approved?

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

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

  • Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
    Patent 10,159,682
    Issued: December 25, 2018
    Assignee(s): CASSIOPEA S.P.A.

    The present invention refers to a new enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17α,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone-17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate.

    Patent expiration dates:

    • August 14, 2028
      ✓ 
      Patent use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE
  • Patent 11,207,332

    Patent expiration dates:

    • November 20, 2028
      ✓ 
      Patent use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE
      ✓ 
      Drug product
  • 17α, 21-dihydroxypregnene esters as antiandrogenic agents
    Patent 8,143,240
    Issued: March 27, 2012
    Inventor(s): Ajani; Mauro & Moro; Luigi
    Assignee(s): Cosmo S.p.A.

    17α,21-Dihydroxypregna-4,9-diene-3,20-dione and 17α,21-dihydroxypregna-4-ene-3,20-dione 17 and/or 21 esters of having remarkable antiandrogenic activity, and the processes for the preparation thereof.

    Patent expiration dates:

    • January 12, 2023
      ✓ 
      Patent use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE
  • Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
    Patent 8,785,427
    Issued: July 22, 2014
    Assignee(s): Cosmo Dermatos Srl

    The present invention refers to a new enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17α,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone 17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate.

    Patent expiration dates:

    • July 25, 2030
      ✓ 
      Drug product
  • 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents
    Patent 8,865,690
    Issued: October 21, 2014
    Assignee(s): Cosmo Dermatos Srl

    17α,21-Dihydroxypregna-4,9(11)-diene-3,20-dione and 17α,21-dihydroxypregna-4-ene-3,20-dione 17 and/or 21 esters thereof having remarkable antiandrogenic activity, and the processes for the preparation thereof.

    Patent expiration dates:

    • July 24, 2023
      ✓ 
      Patent use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE
  • 17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents
    Patent 9,211,295
    Issued: December 15, 2015
    Assignee(s): CASSIOPEA S.P.A.

    17α,21-Dihydroxypregna-4,9(11)-diene-3,20-dione and 17α,21-dihydroxypregna-4-ene-3,20-dione 17 and/or 21 esters having remarkable antiandrogenic activity are provided, along with methods of using these compounds and processes for their preparation.

    Patent expiration dates:

    • July 24, 2023
      ✓ 
      Drug product
  • Enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives
    Patent 9,433,628
    Issued: September 6, 2016
    Assignee(s): Cassiopea SPA

    The present invention refers to a new enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17α,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone 17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate.

    Patent expiration dates:

    • February 28, 2029
      ✓ 
      Drug product
  • Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
    Patent 9,486,458
    Issued: November 8, 2016
    Assignee(s): Cassiopea SPA

    The present invention refers to a new enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17α,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone-17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate.

    Patent expiration dates:

    • July 24, 2028
      ✓ 
      Patent use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE

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:

    • August 26, 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.