FDA Orange Book · active-ingredient family
Benzoyl peroxide; tretinoin
Benzoyl peroxide; tretinoin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TWYNEO · NDA 214902
1
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TWYNEORLD | MAYNE PHARMA | NDA 214902 | — | Jul 26, 2021 |
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8617580 | 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-3194 |
| 10653899 | Dec 30, 2030 | in 4 yr 7 mo | ProductU-3194 |
| 12070629 | Dec 30, 2030 | in 4 yr 7 mo | ProductU-3987 |
| 11071878 | Dec 30, 2030 | in 4 yr 7 mo | Product |
| 12053546 | Jun 29, 2032 | in 6 yr 1 mo | Product |
| 12357602 | Jul 12, 2038 | in 12 yr 3 mo | ProductU-3987 |
| 10420743 | Jul 12, 2038 | in 12 yr 3 mo | U-3194 |
| 12295935 | Dec 27, 2040 | in 14 yr 9 mo | U-3987 |
| 12257348 | May 23, 2041 | in 15 yr 2 mo | ProductU-3987 |
| 12491163 | May 23, 2041 | in 15 yr 2 mo | ProductU-3987 |
| 12133919 | May 23, 2041 | in 15 yr 2 mo | ProductU-3987 |
Benzoyl peroxide; tretinoin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
