clascoterone · Sun Pharm · NDA 213433
Winlevi
Earliest generic entry, as listed
26 Aug 2031
Blocked by patent: US 9433628.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9433628 | substance, product | 26 Aug 2031 |
| US 8785427 | product | 25 Jul 2030 |
| US 11207332 | product, use U-3280 | 20 Nov 2028 |
| US 10159682 | use U-2942 | 14 Aug 2028 |
| US 11938141 | product | 24 Jul 2028 |
| US 12337002 | product, use U-3280 | 24 Jul 2028 |
| US 9486458 | use U-2942 | 24 Jul 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213433 · 001 · RLD | cream, topical | 1% | 26 Aug 2031 |