FDA Orange Book · active-ingredient family
Benzoyl peroxide
Benzoyl peroxide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:EPSOLAY · NDA 214510
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPSOLAYRLD | MAYNE PHARMA | NDA 214510 | — | Apr 22, 2022 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12350382 | Feb 03, 2028 | in 1 yr 8 mo | Product |
| 12156946 | Feb 03, 2028 | in 1 yr 8 mo | Product |
| 9868103 | Aug 08, 2028 | in 2 yr 2 mo | ProductU-3356 |
| 9687465 | Nov 27, 2032 | in 6 yr 6 mo | ProductU-3356 |
| 10945987 | Feb 19, 2040 | in 13 yr 10 mo | U-3356 |
| 11877997 | Feb 19, 2040 | in 13 yr 10 mo | U-3356 |
| 10933046 | Feb 19, 2040 | in 13 yr 10 mo | ProductU-3357 |
| 11541026 | Feb 19, 2040 | in 13 yr 10 mo | U-3356 |
| 11986456 | Feb 19, 2040 | in 13 yr 10 mo | U-3947 |
| 11865100 | Feb 19, 2040 | in 13 yr 10 mo | U-3357 |
| 11426378 | Aug 18, 2040 | in 14 yr 4 mo | U-3356 |
| 12295935 | Dec 27, 2040 | in 14 yr 9 mo | U-3356 |
| 11628155 | Dec 27, 2040 | in 14 yr 9 mo | U-3356 |
| 12257348 | May 23, 2041 | in 15 yr 2 mo | ProductU-3947 |
Benzoyl peroxide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
