FDA Orange Book
Generic for Epiduo
Epiduo contains adapalene and 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
Yes. The generic name for Epiduo is adapalene and benzoyl peroxide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Epiduo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 0.1%;2.5% | Discontinued | None | 4 | AB |
NDA 022320, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic adapalene and benzoyl peroxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 205033 | AB (A-rated, therapeutically equivalent) | January 23, 2018 | 0.1%;2.5% |
| SUN PHARMA CANADA INC | 206959 | AB (A-rated, therapeutically equivalent) | January 24, 2018 | 0.1%;2.5% |
| ENCUBE ETHICALS PRIVATE LTD | 206164 | AB (A-rated, therapeutically equivalent) | May 23, 2018 | 0.1%;2.5% |
| GLENMARK PHARMACEUTICALS LTD | 208108 | AB (A-rated, therapeutically equivalent) | November 8, 2019 | 0.1%;2.5% |
Epiduo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8080537 | July 18, 2027 | Method of use | U-1078 | 022320 |
| 8129362 | July 18, 2027 | Method of use | U-1078 | 022320 |
| 8071644 | July 18, 2027 | Drug product | U-1078 | 022320 |
Questions
Is there a generic for Epiduo?
Yes. The generic name for Epiduo is adapalene and benzoyl peroxide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Epiduo?
The active ingredient in Epiduo is adapalene and benzoyl peroxide, per the FDA Orange Book.
When does the Epiduo patent expire?
The last patent listed for Epiduo in the Orange Book expires July 18, 2027. 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.