FDA Orange Book
Generic for Onexton
Onexton contains clindamycin 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 Onexton is clindamycin and benzoyl peroxide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Onexton products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 3.75%;EQ 1.2% BASE | Marketed (Rx) | AB | 3 | AB |
NDA 050819, held by BAUSCH HEALTH AMERICAS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clindamycin and benzoyl peroxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 208683 | AB (A-rated, therapeutically equivalent) | June 5, 2018 | 3.75%;EQ 1.2% BASE |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 209610 | AB (A-rated, therapeutically equivalent) | August 20, 2024 | 3.75%;EQ 1.2% BASE |
| ACTAVIS LABORATORIES UT INC | 208757 | AB (A-rated, therapeutically equivalent) | August 7, 2026 | 3.75%;EQ 1.2% BASE |
Onexton patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9561208 | June 3, 2029 | Drug product | U-916 | 050819 |
| 10220049 | June 3, 2029 | Drug product | U-916 | 050819 |
| 9504704 | June 3, 2029 | Drug product | U-134 | 050819 |
| 9504704 | June 3, 2029 | Drug product | U-818 | 050819 |
| 9504704 | June 3, 2029 | Drug product | U-916 | 050819 |
| 9504704 | June 3, 2029 | Drug product | U-124 | 050819 |
| 10137142 | June 3, 2029 | Drug product | U-916 | 050819 |
| 8288434 | August 5, 2029 | Drug product | U-818 | 050819 |
| 8288434 | August 5, 2029 | Drug product | U-124 | 050819 |
| 8288434 | August 5, 2029 | Drug product | U-134 | 050819 |
| 8288434 | August 5, 2029 | Drug product | U-1033 | 050819 |
| 8288434 | August 5, 2029 | Drug product | U-921 | 050819 |
| 8288434 | August 5, 2029 | Drug product | U-916 | 050819 |
Onexton NDC codes
Questions
Is there a generic for Onexton?
Yes. The generic name for Onexton is clindamycin and benzoyl peroxide. 3 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 Onexton?
The active ingredient in Onexton is clindamycin and benzoyl peroxide, per the FDA Orange Book.
When does the Onexton patent expire?
The last patent listed for Onexton in the Orange Book expires August 5, 2029. 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.