Orange Book product · Brand (NDA)
CABTREO
ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
At a glance
Oct 20, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 2023
2 yr 8 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 20, 2026
in 4 mo
Patent 10220049 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 10624918 expires
Listed method-of-use patent (U-3713) expiration.
Jun 03, 2029
in 3 yr
Patent 9561208 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 12128059 expires
Listed drug product patent expiration.
Jul 31, 2040
in 14 yr 4 mo
Patent 12133859 expires
Listed drug product patent expiration.
Jul 31, 2040
in 14 yr 4 mo
Patent 12138278 expires
Listed drug product patent expiration.
Jul 31, 2040
in 14 yr 4 mo
Patent 12616710 expires
Listed drug product patent expiration.
Jul 31, 2040
in 14 yr 4 mo
Patent 11389467 expires
Listed drug product patent expiration.
Dec 28, 2040
in 14 yr 9 mo
Pharmaceutical detail
Active ingredient
ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Strength
0.15%;3.1%;1.2%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 216632
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 20, 2026
in 4 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10220049 | Jun 03, 2029 | in 3 yr | ProductU-3713 |
| 10624918 | Jun 03, 2029 | in 3 yr | U-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 |
| 12133859 | Jul 31, 2040 | in 14 yr 4 mo | Product |
| 12138278 | Jul 31, 2040 | in 14 yr 4 mo | Product |
| 12616710 | Jul 31, 2040 | in 14 yr 4 mo | Product |
| 11389467 | Dec 28, 2040 | in 14 yr 9 mo | ProductU-3713 |

