clevidipine · Chiesi · NDA 022156
Cleviprex
Earliest generic entry, as listed · earliest of 2 marketed strengths
10 Oct 2031
Blocked by patent: US 10010537, US 11103490, US 8658676.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10010537 | drug product · sets the listed date | 10 Oct 2031 |
| US 11103490 | drug product · sets the listed date | 10 Oct 2031 |
| US 8658676 | drug product · sets the listed date | 10 Oct 2031 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022156 · 001 · RLD | emulsion, intravenous | 25MG/50ML (0.5MG/ML) | 10 Oct 2031 |
| 022156 · 002 · RLD | emulsion, intravenous | 50MG/100ML (0.5MG/ML) | 10 Oct 2031 |
| 022156 · 003 · RLD · discontinued | emulsion, intravenous | 125MG/250ML (0.5MG/ML) | 10 Oct 2031 |