nerandomilast · Boehringer Ingelheim · NDA 218764
Jascayd
Earliest generic entry, as listed · earliest of 2 marketed strengths
22 Oct 2038
Blocked by patent: US 11406638, US 11813266. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
7 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11406638 | use U-4297, U-4373 | 22 Oct 2038 |
| US 11406638 listing row | use U-4297 · sets the listed date | 22 Oct 2038 |
| US 11406638 listing row | use U-4373 · sets the listed date | 22 Oct 2038 |
| US 11813266 | use U-4292, U-4372 | 22 Oct 2038 |
| US 11813266 listing row | use U-4292 · sets the listed date | 22 Oct 2038 |
| US 11813266 listing row | use U-4372 · sets the listed date | 22 Oct 2038 |
| US 9802954 | use U-4298 | 19 Feb 2034 |
| US 8609670 | drug substance | 23 Aug 2032 |
| US 8754073 | drug substance, drug product, use U-4298 | 26 Nov 2029 |
Exclusivities · 3 unexpired
| ODE-546 | orphan drug (7 years) | 7 Oct 2032 |
| NCE | new chemical entity (5 years) | 7 Oct 2030 |
| I-979 | new indication (3 years) | 19 Dec 2028 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218764 · 001 · RLD | tablet, oral | 9MG | 22 Oct 2038 |
| 218764 · 002 · RLD | tablet, oral | 18MG | 22 Oct 2038 |