tradipitant · Vanda Pharms Inc · NDA 220152
Nereus
Earliest generic entry, as listed
9 Aug 2036
Blocked by patent: US 12318375. 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 12318375 | use U-4396 · sets the listed date | 9 Aug 2036 |
| US 10772880 | use U-4396 | 4 Mar 2036 |
| US 10821099 | use U-4396 | 4 Mar 2036 |
| US 11324735 | use U-4396 | 4 Mar 2036 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 30 Dec 2030 |
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 |
|---|---|---|---|
| 220152 · 001 · RLD | capsule, oral | 85MG | 9 Aug 2036 |