linerixibat · Intercept · NDA 220295
Lynavoy
Earliest generic entry, as listed
17 Mar 2033
Blocked by exclusivity: ODE-517.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9040518 | substance, product | 6 Sep 2031 |
Exclusivities · 2 unexpired
| ODE-517 | orphan drug (7 years) | 17 Mar 2033 |
| NCE | new chemical entity (5 years) | 17 Mar 2031 |
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 |
|---|---|---|---|
| 220295 · 001 · RLD | tablet, oral | 40MG | 17 Mar 2033 |