elafibranor · Ipsen · NDA 218860
Iqirvo
Earliest generic entry, as listed
5 Mar 2044
Blocked by patent: US 12673035.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12673035 | drug product, use U-1854 · sets the listed date | 5 Mar 2044 |
| US 11185519 | use U-3955 | 30 Mar 2037 |
| US 11331292 | use U-1854 | 30 Mar 2037 |
| US 11850223 | use U-1854 | 30 Mar 2037 |
| US 11857523 | use U-3955 | 30 Mar 2037 |
| US 12233038 | use U-1854 | 30 Mar 2037 |
| US 12295927 | use U-1854 | 30 Mar 2037 |
| US 12295928 | use U-1854 | 30 Mar 2037 |
| US 12310935 | use U-1854 | 30 Mar 2037 |
| US 12589086 | use U-4473 | 30 Mar 2037 |
Exclusivities · 2 unexpired
| ODE-486 | orphan drug (7 years) | 10 Jun 2031 |
| NCE | new chemical entity (5 years) | 10 Jun 2029 |
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 |
|---|---|---|---|
| 218860 · 001 · RLD | tablet, oral | 80MG | 5 Mar 2044 |