terlipressin acetate · Mallinckrodt Ireland · NDA 022231
Terlivaz
Earliest generic entry, as listed
5 Apr 2037
Blocked by patent: US 10335452. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10335452 | use U-3711 · sets the listed date | 5 Apr 2037 |
Exclusivities · 2 unexpired
| ODE-406 | orphan drug (7 years) | 14 Sep 2029 |
| NCE | new chemical entity (5 years) | 14 Sep 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 |
|---|---|---|---|
| 022231 · 001 · RLD | powder, intravenous | EQ 0.85MG BASE/VIAL | 5 Apr 2037 |