Generic Epsolay Availability
Last updated on Sep 10, 2026.
Epsolay is a brand name of benzoyl peroxide topical, approved by the FDA in the following formulation:
| Manufacturer | Approval date | Strengths [RLD] |
|---|---|---|
| MAYNE PHARMA | April 22, 2022 |
|
Has a generic version of Epsolay been approved?
No, the FDA has not approved a generic version of Epsolay.
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.
Patent protection
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development. These patents may include claims related to the drug's formulation, manufacturing process, or other aspects.
| Patent Title | Method for treatment of rosacea in patients aged 65 years and older |
|---|---|
| Patent Number | 10,933,046 |
| Issue Date | March 2, 2021 |
| Inventor | Toledano Ofer & Levy-Hacham Ofra & Nov Ori & Ram Vered |
| Current Assignee | SOL-GEL TECHNOLOGIES, LTD. |
| Patent Description |
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...
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 Expiry Dates |
February 19, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER Drug Product: Yes |
| Patent Title | Method for providing early onset of action in the treatment of rosacea |
|---|---|
| Patent Number | 10,945,987 |
| Issue Date | March 16, 2021 |
| Inventor | Toledano Ofer & Levy-Hacham Ofra & Nov Ori & Ram Vered |
| Current Assignee | SOL-GEL TECHNOLOGIES LTD. |
| Patent Description |
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...
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 Expiry Dates |
February 19, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| Patent Title | Method for long-term treatment of rosacea |
|---|---|
| Patent Number | 11,426,378 |
| Issue Date | August 30, 2022 |
| Inventor | Toledano Ofer & Levy-Hacham Ofra & Nov Ori & Ram Vered |
| Current Assignee | SOL-GEL TECHNOLOGIES LTD. |
| Patent Description |
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...
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 Expiry Dates |
August 18, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| Patent Title | Method for treatment of rosacea |
|---|---|
| Patent Number | 11,541,026 |
| Issue Date | January 3, 2023 |
| Inventor | Arkin; Moshe et al. |
| Current Assignee | SOL-GEL TECHNOLOGIES LTD. (Ness Ziona, IL) |
| Patent Description |
A regimen is described for the therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes from about 2.5% to...
A regimen is described for the therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes from about 2.5% to about 10% benzoyl peroxide as the only active ingredient, and a pharmaceutically acceptable carrier or excipient. The regimen achieves, in a group of such subjects, a primary measure of success of at least about 9%, at least about 25%, at least about 40%, or at least about 47%, after application of said pharmaceutical composition once daily for at least about 2 weeks, at least about 4 weeks, at least about 8 weeks, or at least about 12 weeks, respectively.
|
| Patent Expiry Dates |
February 19, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| Patent Title | Method for therapeutic treatment of rosacea |
|---|---|
| Patent Number | 11,628,155 |
| Issue Date | April 18, 2023 |
| Inventor | Toledano; Ofer et al. |
| Current Assignee | SOL-GEL TECHNOLOGIES LTD. (Ness Ziona, IL) |
| Patent Description |
A regimen and a pharmaceutical composition for the treatment of rosacea are described. The regimen includes topically applying to the skin of a subject in need of such treatment a pharmaceutical composition comprising about 1% w/w to about 10% w/w...
A regimen and a pharmaceutical composition for the treatment of rosacea are described. The regimen includes topically applying to the skin of a subject in need of such treatment a pharmaceutical composition comprising about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and the pharmaceutically acceptable carrier or excipient, where the benzoyl peroxide is the only active ingredient in the pharmaceutical composition, and the pharmaceutical composition is a cream or an emulsion.
|
| Patent Expiry Dates |
December 27, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| Patent Title | Method for treatment of rosacea in patients aged 65 years and older |
|---|---|
| Patent Number | 11,865,100 |
| Issue Date | January 9, 2024 |
| Inventor | Toledano; Ofer et al. |
| Current Assignee | Sol-Gel Technologies Ltd. (Ness Ziona, IL) |
| Patent Description |
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...
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 Expiry Dates |
February 19, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER |
| Patent Title | Method for providing early onset of action in the treatment of rosacea |
|---|---|
| Patent Number | 11,877,997 |
| Issue Date | January 23, 2024 |
| Inventor | Toledano; Ofer et al. |
| Current Assignee | Sol-Gel Technologies Ltd. (Ness Ziona, IL) |
| Patent Description |
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...
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 Expiry Dates |
February 19, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| Patent Title | Method for treatment of rosacea |
|---|---|
| Patent Number | 11,986,456 |
| Issue Date | May 21, 2024 |
| Inventor | Arkin; Moshe et al. |
| Current Assignee | Sol-Gel Technologies Ltd. (Ness Ziona, IL) |
| Patent Description |
A regimen is described for the therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes from about 2.5% to...
A regimen is described for the therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes from about 2.5% to about 10% benzoyl peroxide as the only active ingredient, and a pharmaceutically acceptable carrier or excipient. The regimen achieves, in a group of such subjects, a primary measure of success of at least about 9%, at least about 25%, at least about 40%, or at least about 47%, after application of said pharmaceutical composition once daily for at least about 2 weeks, at least about 4 weeks, at least about 8 weeks, or at least about 12 weeks, respectively.
|
| Patent Expiry Dates |
February 19, 2040
Patent Use: TOPICAL TREATMENT OF ROSACEA |
| Patent Title | Method for preparing particles comprising metal oxide coating and particles with metal oxide coating |
|---|---|
| Patent Number | 12,156,946 |
| Issue Date | December 3, 2024 |
| Inventor | Toledano; Ofer et al. |
| Current Assignee | Sol-Gel Technologies Ltd. (Ness Ziona, IL) |
| Patent Description |
The invention relates to a process for coating a solid, water-insoluble particulate matter, with a metal oxide comprising: (a) contacting the solid, water-insoluble particulate matter with an ionic additive and an aqueous medium to obtain a...
The invention relates to a process for coating a solid, water-insoluble particulate matter, with a metal oxide comprising: (a) contacting the solid, water-insoluble particulate matter with an ionic additive and an aqueous medium to obtain a dispersion of said particulate matter having positive charges on its surface; (b) subjecting the particulate matter to a coating procedure comprising precipitating a metal oxide salt onto the surface of the particulate matter to form a metal oxide layer thereon to thereby obtain particulate matter coated by a metal oxide coating layer; (c) repeating step (b) at least 4 more times; and (d) aging said coating layer. The invention further relates to particles comprising a particulate matter coated by a metal oxide layer, to a use of the particles for topical administration, and to a method for preventing, reducing, or eliminating pests at a locus, using the particles.
|
| Patent Expiry Dates |
February 3, 2028
Drug Product: Yes |
| Patent Title | Stabilized microcapsules, method of their preparation and uses thereof |
|---|---|
| Patent Number | 12,257,348 |
| Issue Date | March 25, 2025 |
| Inventor | Toledano; Ofer et al. |
| Current Assignee | Sol-Gel Technologies Ltd. (Ness Ziona, IL) |
| Patent Description |
The present application is directed to stabilized core-shell microcapsules comprising a core of benzoyl peroxide (BPO) or all trans retinoic acid (ATRA) and a metal-oxide shell; and to pharmaceutical compositions and methods of use thereof.
|
| Patent Expiry Dates |
May 23, 2041
Patent Use: TOPICAL TREATMENT OF ROSACEA Drug Product: Yes |
| Patent Title | Method for therapeutic treatment of rosacea |
|---|---|
| Patent Number | 12,295,935 |
| Issue Date | May 13, 2025 |
| Inventor | Toledano; Ofer et al. |
| Current Assignee | Sol-Gel Technologies Ltd. (Ness Ziona, IL) |
| Patent Description |
A regimen and a pharmaceutical composition for the treatment of a skin condition and/or skin affliction are described. The regimen includes topically applying to the skin of a subject in need of such treatment a pharmaceutical composition comprising...
A regimen and a pharmaceutical composition for the treatment of a skin condition and/or skin affliction are described. The regimen includes topically applying to the skin of a subject in need of such treatment a pharmaceutical composition comprising about 2.5% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient.
|
| Patent Expiry Dates |
December 27, 2040
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| Patent Title | Method for preparing particles comprising metal oxide coating and particles with metal oxide coating |
|---|---|
| Patent Number | 12,350,382 |
| Issue Date | July 8, 2025 |
| Inventor | Toledano; Ofer et al. |
| Current Assignee | Mayne Pharma LLC (Raleigh, NC) |
| Patent Description |
The invention relates to a process for coating a solid, water-insoluble particulate matter, with a metal oxide comprising: (a) contacting the solid, water-insoluble particulate matter with an ionic additive and an aqueous medium to obtain a...
The invention relates to a process for coating a solid, water-insoluble particulate matter, with a metal oxide comprising: (a) contacting the solid, water-insoluble particulate matter with an ionic additive and an aqueous medium to obtain a dispersion of said particulate matter having positive charges on its surface; (b) subjecting the particulate matter to a coating procedure comprising precipitating a metal oxide salt onto the surface of the particulate matter to form a metal oxide layer thereon to thereby obtain particulate matter coated by a metal oxide coating layer; (c) repeating step (b) at least 4 more times; and (d) aging said coating layer. The invention further relates to particles comprising a particulate matter coated by a metal oxide layer, to a use of the particles for topical administration, and to a method for preventing, reducing, or eliminating pests at a locus, using the particles.
|
| Patent Expiry Dates |
February 3, 2028
Drug Product: Yes |
| Patent Title | Compositions for the treatment of rosacea |
|---|---|
| Patent Number | 9,687,465 |
| Issue Date | June 27, 2017 |
| Inventor | Sertchook Hanan & Toledano Ofer & Bar-Simantov Haim |
| Current Assignee | SOL-GEL TECHNOLOGIES LTD. |
| Patent Description |
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 Expiry Dates |
November 27, 2032
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER Drug Product: Yes |
| Patent Title | Metal oxide coating of water insoluble ingredients |
|---|---|
| Patent Number | 9,868,103 |
| Issue Date | January 16, 2018 |
| Inventor | Toledano Ofer & Sertchook Hanan & Loboda Natalia & Bar-Simantov Haim |
| Current Assignee | SOL-GEL TECHNOLOGIES LTD. |
| Patent Description |
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...
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 Expiry Dates |
August 8, 2028
Patent Use: TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER Drug Product: Yes |
More about Epsolay (benzoyl peroxide topical)
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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.
