birch triterpenes · Chiesi · NDA 215064
Filsuvez
Earliest generic entry, as listed
4 Jan 2039
Blocked by patent: US 11083733, US 11266660, US 12268695.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11083733 | drug product · sets the listed date | 4 Jan 2039 |
| US 11266660 | use U-3811 · sets the listed date | 4 Jan 2039 |
| US 12268695 | use U-3811 · sets the listed date | 4 Jan 2039 |
| US 9352041 | use U-3811 | 24 Nov 2030 |
| US 9827214 | use U-3811 | 24 Nov 2030 |
| US 8828444 | drug product | 21 Jun 2027 |
Exclusivities · 2 unexpired
| ODE-460 | orphan drug (7 years) | 18 Dec 2030 |
| NCE | new chemical entity (5 years) | 18 Dec 2028 |
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 |
|---|---|---|---|
| 215064 · 001 · RLD | gel, topical | 10% | 4 Jan 2039 |