FDA Orange Book
Is there a generic for Epsolay?
Epsolay contains benzoyl peroxide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Epsolay (benzoyl peroxide). The Orange Book shows its last listed patent expires May 23, 2041.
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Epsolay products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 5% | Marketed (Rx) | None | 0 | None |
NDA 214510, held by MAYNE PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Epsolay patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12350382 | February 3, 2028 | Drug product | None | 214510 |
| 12156946 | February 3, 2028 | Drug product | None | 214510 |
| 9868103 | August 8, 2028 | Drug product | U-3356 | 214510 |
| 9687465 | November 27, 2032 | Drug product | U-3356 | 214510 |
| 10945987 | February 19, 2040 | Method of use | U-3356 | 214510 |
| 11877997 | February 19, 2040 | Method of use | U-3356 | 214510 |
| 10933046 | February 19, 2040 | Drug product | U-3357 | 214510 |
| 11541026 | February 19, 2040 | Method of use | U-3356 | 214510 |
| 11986456 | February 19, 2040 | Method of use | U-3947 | 214510 |
| 11865100 | February 19, 2040 | Method of use | U-3357 | 214510 |
| 11426378 | August 18, 2040 | Method of use | U-3356 | 214510 |
| 12295935 | December 27, 2040 | Method of use | U-3356 | 214510 |
| 11628155 | December 27, 2040 | Method of use | U-3356 | 214510 |
| 12257348 | May 23, 2041 | Drug product | U-3947 | 214510 |
Epsolay NDC codes
Questions
Is there a generic for Epsolay?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Epsolay (benzoyl peroxide). The Orange Book shows its last listed patent expires May 23, 2041.
What is the generic name for Epsolay?
The active ingredient in Epsolay is benzoyl peroxide, per the FDA Orange Book.
When does the Epsolay patent expire?
The last patent listed for Epsolay in the Orange Book expires May 23, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.