levacetylleucine · Intrabio · NDA 219132
Aqneursa
Earliest generic entry, as listed
19 Apr 2037
Blocked by patent: US 11400067, US 12144792, US 12433862, US 12433863. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11400067 | use U-4170 | 19 Apr 2037 |
| US 12144792 | use U-4603 | 19 Apr 2037 |
| US 12433862 | use U-4284 | 19 Apr 2037 |
| US 12433863 | use U-4285 | 19 Apr 2037 |
Exclusivities · 2 unexpired
| ODE-498 | orphan drug (7 years) | 24 Sep 2031 |
| NCE | new chemical entity (5 years) | 24 Sep 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 |
|---|---|---|---|
| 219132 · 001 · RLD | for suspension, oral | 1GM/PACKET | 19 Apr 2037 |