viltolarsen · Nippon Shinyaku · NDA 212154
Viltepso
Earliest generic entry, as listed
3 Apr 2034
Blocked by patent: US 9079934.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9079934 | drug substance, drug product · sets the listed date | 3 Apr 2034 |
| US 10870676 | drug substance, drug product, use U-3039 | 31 Aug 2031 |
Exclusivities · 1 unexpired
| ODE-280 | orphan drug (7 years) | 12 Aug 2027 |
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 |
|---|---|---|---|
| 212154 · 001 · RLD | solution, intravenous | 250MG/5ML (50MG/ML) | 3 Apr 2034 |