FDA Orange Book
Is there a generic for Cabtreo?
Cabtreo contains clindamycin, benzoyl peroxide and adapalene. 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 Cabtreo (clindamycin, benzoyl peroxide and adapalene). The Orange Book shows its last listed patent expires December 28, 2040 and its last listed exclusivity ends October 20, 2026.
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Cabtreo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 0.15%;3.1%;1.2% | Marketed (Rx) | None | 0 | None |
NDA 216632, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cabtreo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10624918 | June 3, 2029 | Method of use | U-3713 | 216632 |
| 10220049 | June 3, 2029 | Drug product | U-3713 | 216632 |
| 9561208 | June 3, 2029 | Drug product | U-3713 | 216632 |
| 8288434 | August 5, 2029 | Drug product | U-3713 | 216632 |
| 12128059 | July 31, 2040 | Drug product | U-3713 | 216632 |
| 12616710 | July 31, 2040 | Drug product | None | 216632 |
| 12138278 | July 31, 2040 | Drug product | None | 216632 |
| 12133859 | July 31, 2040 | Drug product | None | 216632 |
| 11389467 | December 28, 2040 | Drug product | U-3713 | 216632 |
Cabtreo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | October 20, 2026 | 216632 |
Cabtreo NDC codes
Questions
Is there a generic for Cabtreo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cabtreo (clindamycin, benzoyl peroxide and adapalene). The Orange Book shows its last listed patent expires December 28, 2040 and its last listed exclusivity ends October 20, 2026.
What is the generic name for Cabtreo?
The active ingredient in Cabtreo is clindamycin, benzoyl peroxide and adapalene, per the FDA Orange Book.
When does the Cabtreo patent expire?
The last patent listed for Cabtreo in the Orange Book expires December 28, 2040. 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.