Orange Book product · Brand (NDA)
WINLEVI
CLASCOTERONE
At a glance
Aug 26, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2020
5 yr 11 mo ago
Today
Patent 8143240 expires
Listed method-of-use patent (U-2942) expiration.
Jan 12, 2027
in 7 mo
Patent 11938141 expires
Listed drug product patent expiration.
Jul 24, 2028
in 2 yr 2 mo
Patent 12337002 expires
Listed drug product patent expiration.
Jul 24, 2028
in 2 yr 2 mo
Patent 9486458 expires
Listed method-of-use patent (U-2942) expiration.
Jul 24, 2028
in 2 yr 2 mo
Patent 10159682 expires
Listed method-of-use patent (U-2942) expiration.
Aug 14, 2028
in 2 yr 2 mo
Patent 11207332 expires
Listed drug product patent expiration.
Nov 20, 2028
in 2 yr 6 mo
Patent 9433628 expires
Listed drug product patent expiration.
Feb 28, 2029
in 2 yr 9 mo
Patent 8785427 expires
Listed drug product patent expiration.
Jul 25, 2030
in 4 yr 2 mo
Pharmaceutical detail
Active ingredient
CLASCOTERONE
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 213433
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.
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8143240 | Jan 12, 2027 | in 7 mo | U-2942 |
| 11938141 | Jul 24, 2028 | in 2 yr 2 mo | Product |
| 12337002 | Jul 24, 2028 | in 2 yr 2 mo | ProductU-3280 |
| 9486458 | Jul 24, 2028 | in 2 yr 2 mo | U-2942 |
| 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 |
