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Generic Epsolay Availability

Last updated on Nov 7, 2023.

Epsolay is a brand name of benzoyl peroxide topical, approved by the FDA in the following formulation(s):

EPSOLAY (benzoyl peroxide - cream;topical)

Has a generic version of Epsolay been approved?

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

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

  • Method for treatment of rosacea in patients aged 65 years and older
    Patent 10,933,046
    Issued: March 2, 2021
    Inventor(s): Toledano Ofer & Levy-Hacham Ofra & Nov Ori & Ram Vered
    Assignee(s): SOL-GEL TECHNOLOGIES, LTD.

    A regimen for the therapeutic treatment of rosacea in subjects aged 65 years and older, the regimen comprising topically applying to the skin of a subject aged 65 years and older in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition.

    Patent expiration dates:

    • February 19, 2040
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
  • Method for providing early onset of action in the treatment of rosacea
    Patent 10,945,987
    Issued: March 16, 2021
    Inventor(s): Toledano Ofer & Levy-Hacham Ofra & Nov Ori & Ram Vered
    Assignee(s): SOL-GEL TECHNOLOGIES LTD.

    A regimen is described for providing early onset of action in the therapeutic treatment of rosacea including topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes about 1% to about 10% benzoyl peroxide as the only active ingredient, and a pharmaceutically acceptable carrier or excipient. The pharmaceutical composition is applied once daily for a period of at least about 2, 4, 8 or 12 weeks. Based on early onset of action, a primary measure of success is at least about 9%, primary measure of success being defined as a 2-grade improvement in IGA of clear or almost clear; and a secondary measure of success is at least about 40%, secondary measure of success being defined as mean inflammatory lesion count percent reduction from baseline, after at least about 2 weeks of treatment.

    Patent expiration dates:

    • February 19, 2040
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
  • Method for long-term treatment of rosacea
    Patent 11,426,378
    Issued: August 30, 2022
    Inventor(s): Toledano Ofer & Levy-Hacham Ofra & Nov Ori & Ram Vered
    Assignee(s): SOL-GEL TECHNOLOGIES LTD.

    A regimen for the long-term therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject. The pharmaceutical composition includes about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient. The benzoyl peroxide is the only active ingredient in the pharmaceutical composition, and the pharmaceutical composition is applied once daily for a period of about 52 weeks, to achieve, in a group of such subjects, a success rate of about 75%.

    Patent expiration dates:

    • August 18, 2040
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
  • Patent 11,541,026
    Issued: November 30, -0001

    Patent expiration dates:

    • February 19, 2040
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
  • Patent 11,628,155
    Issued: November 30, -0001

    Patent expiration dates:

    • December 27, 2040
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
  • Compositions for the treatment of rosacea
    Patent 9,687,465
    Issued: June 27, 2017
    Inventor(s): Sertchook Hanan & Toledano Ofer & Bar-Simantov Haim
    Assignee(s): SOL-GEL TECHNOLOGIES LTD.

    The present invention relates to pharmaceutical compositions for topical use (including also dermatological compositions), for treating skin conditions and afflictions, such as rosacea and symptoms and conditions associated there from.

    Patent expiration dates:

    • November 27, 2032
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
  • Metal oxide coating of water insoluble ingredients
    Patent 9,868,103
    Issued: January 16, 2018
    Inventor(s): Toledano Ofer & Sertchook Hanan & Loboda Natalia & Bar-Simantov Haim
    Assignee(s): SOL-GEL TECHNOLOGIES LTD.

    The invention relates to process for coating a solid, water-insoluble particulate matter, with a metal oxide comprising: (a) contacting the solid water-insoluble particulate matter with a cationic additive in an aqueous medium to obtain a dispersion of said particulate matter having a positive zeta potential; (b) coating the solid water-insoluble particulate matter by precipitation of a metal oxide salt onto the surface of the particulate matter, forming a metal oxide layer thereon; and (c) aging said coating layer. The invention further relates to coated particulate matter obtained by the process and to compositions comprising solid, water-insoluble particulate matter, coated by a metal oxide layer, the particulate matter being a dermatological active agent or a pesticide. The invention additionally relates to methods of treating a surface condition in a subject using compositions comprising solid, water insoluble dermatologically active agent, coated by a metal oxide layer.

    Patent expiration dates:

    • August 8, 2028
      ✓ 
      Patent use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER
      ✓ 
      Drug product

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:

    • April 22, 2025 - NEW PRODUCT

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.

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