FDA Orange Book · active-ingredient family
Adapalene; benzoyl peroxide; clindamycin phosphate
Adapalene; benzoyl peroxide; clindamycin phosphate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:CABTREO · NDA 216632
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
1
Exclusivity periods
Brand (NDA) products · gel
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CABTREORLD | BAUSCH | NDA 216632 | — | Oct 20, 2023 |
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 20, 2026
in 4 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10624918 | Jun 03, 2029 | in 3 yr | U-3713 |
| 10220049 | Jun 03, 2029 | in 3 yr | ProductU-3713 |
| 9561208 | Jun 03, 2029 | in 3 yr | ProductU-3713 |
| 8288434 | Aug 05, 2029 | in 3 yr 2 mo | ProductU-3713 |
| 12128059 | Jul 31, 2040 | in 14 yr 4 mo | ProductU-3713 |
| 12616710 | Jul 31, 2040 | in 14 yr 4 mo | Product |
| 12138278 | Jul 31, 2040 | in 14 yr 4 mo | Product |
| 12133859 | Jul 31, 2040 | in 14 yr 4 mo | Product |
| 11389467 | Dec 28, 2040 | in 14 yr 9 mo | ProductU-3713 |
Adapalene; benzoyl peroxide; clindamycin phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
