Epsolay Generic: When Will Generic Benzoyl Peroxide Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Epsolay Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? December 2040 About 14 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? May 2041 14 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic benzoyl peroxide is expected to be available in December 2040, about 14 years away. None is for sale yet.
Why December 2040?
It is when Epsolay’s patents 11,628,155 and 12,295,935 end. They cover a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Epsolay’s last patent runs to May 2041, how can a generic come sooner?
The patent that runs to May 2041 (12,257,348) covers the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Epsolay as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Epsolay by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $15M a yearSmaller seller
- FDA approved 2022 April 2022 FDA Orange Book
- Patents listed 14 last runs to May 2041 A generic is expected sooner, in December 2040. See why FDA Orange Book
- Medicare Part D spent $364.7K in 2025, for 304 people CMS Part D Spending by Drug
- Medicaid prescriptions 175 in the last four reported quarters, $121.7K CMS Medicaid drug utilization, to Q1 2026
Epsolay’s Road to a Generic
Epsolay has had the market to itself since the FDA approved it in April 2022 (Mayne Pharma LLC). Its 14 listed patents run to May 2041.
The first generic of Epsolay is expected in December 2040.
Why that month: patents 11,628,155 and 12,295,935, on a way of using it, end then. That is a few months before the last listed patent runs out, in May 2041.
Why a Generic Can Come Before May 2041
The last listed patent runs to May 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Epsolay Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Epsolay’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patents 11,628,155 and 12,295,935, which end in December 2040, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,156,946 | The product’s formulation | February 2028 | Active |
| 12,350,382 | The product’s formulation | February 2028 | Active |
| 9,868,103 | The product’s formulation; a way of using it (U-3356) | August 2028 | Active |
| 9,687,465 | The product’s formulation; a way of using it (U-3356) | November 2032 | Active |
| 10,933,046 | The product’s formulation; a way of using it (U-3357) | February 2040 | Active |
| 10,945,987 | A way of using it (U-3356) | February 2040 | Active |
| 11,541,026 | A way of using it (U-3356) | February 2040 | Active |
| 11,865,100 | A way of using it (U-3357) | February 2040 | Active |
| 11,877,997 | A way of using it (U-3356) | February 2040 | Active |
| 11,986,456 | A way of using it (U-3947) | February 2040 | Active |
| 11,426,378 | A way of using it (U-3356) | August 2040 | Active |
| 11,628,155 Sets the expected month of generic availability | A way of using it (U-3356) | December 2040 | Active |
| 12,295,935 Sets the expected month of generic availability | A way of using it (U-3356) | December 2040 | Active |
| 12,257,348 | The product’s formulation; a way of using it (U-3947) | May 2041 | Active |
Source: FDA Orange Book, application 214510. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Benzoyl Peroxide
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Epsolay yet.
Approved by the FDA
Not yet. The FDA has not approved a generic benzoyl peroxide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic benzoyl peroxide for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Epsolay Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Epsolay, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Epsolay
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Epsolay, before manufacturer rebates.
- $60.9K
- January to March 2026, the latest CMS has posted
For 63 people, about $743 per prescription fill - $364.7K
- 2025, the whole year
For 304 people, about $623 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $60,924 | 63 | $742.97 |
| 2025 | $364,728 | 304 | $623.47 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Epsolay only, so no generic is counted in it. What CMS says it is used for: Benzoyl peroxide products are usually used to treat mild to moderate acne. When used to treat acne, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel.
Medicaid Prescriptions by Quarter
175 prescriptions in the four quarters to Q1 2026, $121.7K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 45 | $35,353 |
| Q4 2025 | 49 | $39,324 |
| Q3 2025 | 28 | $17,889 |
| Q2 2025 | 53 | $29,158 |
| Q1 2025 | 70 | $46,026 |
Source: CMS Medicaid State Drug Utilization Data, over Epsolay’s own package codes.
Epsolay Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 5% | Cream | Topical | April 2022 | Prescription reference product |
Source: FDA Orange Book, Mayne Pharma LLC. Listed for sale today by Galderma Laboratories, L.P., Sol-Gel Technologies Inc. and Mayne Pharma Commercial LLC (FDA NDC Directory).
Epsolay NDC Codes and Packages
Each Epsolay package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00299-5890-00 | 50 mg/g cream | bottle of 3 g | Galderma Laboratories, L.P. |
| 00299-5890-00 | 50 mg/g cream | bottle of 3 g | Galderma Laboratories, L.P. |
| 00299-5890-30 | 50 mg/g cream | bottle of 30 g | Galderma Laboratories, L.P. |
| 00299-5890-30 | 50 mg/g cream | bottle of 30 g | Galderma Laboratories, L.P. |
| 51862-0772-30 | BENZOYL PEROXIDE 30 mg/g cream | bottle of 30 g | Mayne Pharma Commercial LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Epsolay’s own FDA approval (NDA 214510) are listed, never a generic. Some codes belong to companies that repackage Epsolay: it is the same medicine in a different package.
What a Generic Epsolay Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Epsolay as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Epsolay”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Epsolay
Is there a generic for Epsolay right now?
No. As of October 9, 2026 no generic benzoyl peroxide is listed for sale in the FDA NDC Directory.
When will Epsolay go generic?
December 2040 is the expected month, and that is probable but not certain. It is when Epsolay’s patents 11,628,155 and 12,295,935 end. They cover a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to May 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic benzoyl peroxide be the same as Epsolay?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Epsolay?
Not yet. The FDA Orange Book lists no approved generic version of Epsolay.
When does the Epsolay patent expire?
The FDA Orange Book lists 14 patents for Epsolay; the last runs to May 2041. The one behind the expected month is patents 11,628,155 and 12,295,935, which end in December 2040. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (December 2040) weighs all of that.
Changes to This Projection
- First generic expected December 2040 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Cresemba IVIsavuconazonium Sulfate2026 to 2027
- IbsrelaTenapanor HydrochlorideAugust 2033
- RevuforjRevumenibNovember 2038
- MyqorzoAficamten2040 to 2041
- UzedyRisperidoneMarch 2042
- ZycuboCopper HistidinateMarch 2042
About Epsolay
- Generic name benzoyl peroxide
- How it is taken On the skin
- Company Mayne Pharma LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with E
- Have a question? A pharmacist answers, free. Ask about Epsolay
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.