FDA Orange Book
Is there a generic for Twyneo?
Twyneo contains tretinoin 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Twyneo (tretinoin and benzoyl peroxide). The Orange Book shows its last listed patent expires May 23, 2041.
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Twyneo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 3%;0.1% | Marketed (Rx) | None | 0 | None |
NDA 214902, 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.
Twyneo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8617580 | February 3, 2028 | Drug product | None | 214902 |
| 12156946 | February 3, 2028 | Drug product | None | 214902 |
| 9868103 | August 8, 2028 | Drug product | U-3194 | 214902 |
| 10653899 | December 30, 2030 | Drug product | U-3194 | 214902 |
| 12070629 | December 30, 2030 | Drug product | U-3987 | 214902 |
| 11071878 | December 30, 2030 | Drug product | None | 214902 |
| 12053546 | June 29, 2032 | Drug product | None | 214902 |
| 12357602 | July 12, 2038 | Drug product | U-3987 | 214902 |
| 10420743 | July 12, 2038 | Method of use | U-3194 | 214902 |
| 12295935 | December 27, 2040 | Method of use | U-3987 | 214902 |
| 12257348 | May 23, 2041 | Drug product | U-3987 | 214902 |
| 12491163 | May 23, 2041 | Drug product | U-3987 | 214902 |
| 12133919 | May 23, 2041 | Drug product | U-3987 | 214902 |
Twyneo NDC codes
Questions
Is there a generic for Twyneo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Twyneo (tretinoin and benzoyl peroxide). The Orange Book shows its last listed patent expires May 23, 2041.
What is the generic name for Twyneo?
The active ingredient in Twyneo is tretinoin and benzoyl peroxide, per the FDA Orange Book.
When does the Twyneo patent expire?
The last patent listed for Twyneo 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.