FDA Orange Book · active-ingredient family
Clascoterone
Clascoterone is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:WINLEVI · NDA 213433
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| WINLEVIRLD | SUN PHARM | NDA 213433 | — | Aug 26, 2020 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8143240 | Jan 12, 2027 | in 7 mo | U-2942 |
| 12337002 | Jul 24, 2028 | in 2 yr 2 mo | ProductU-3280 |
| 9486458 | Jul 24, 2028 | in 2 yr 2 mo | U-2942 |
| 11938141 | Jul 24, 2028 | in 2 yr 2 mo | Product |
| 10159682 | Aug 14, 2028 | in 2 yr 2 mo | U-2942 |
| 11207332 | Nov 20, 2028 | in 2 yr 6 mo | ProductU-3280 |
| 9433628 | Feb 28, 2029 | in 2 yr 9 mo | Product |
| 8785427 | Jul 25, 2030 | in 4 yr 2 mo | Product |
Clascoterone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
