crinecerfont · Neurocrine · NDA 218808, 218820
Crenessity
Earliest generic entry, as listed · earliest of 4 marketed strengths
12 Jan 2043
Blocked by patent: US 12582634.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12582634 | drug substance · sets the listed date | 12 Jan 2043 |
| US 12128033 | drug substance, use U-4049 | 9 Jun 2041 |
| US 10905690 | use U-4049 | 21 Jan 2035 |
| US 11311544 | use U-4049 | 21 Jan 2035 |
| US 11730739 | use U-4049 | 21 Jan 2035 |
Exclusivities · 2 unexpired
| ODE-503 | orphan drug (7 years) | 13 Dec 2031 |
| NCE | new chemical entity (5 years) | 13 Dec 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218808 · 001 · RLD | capsule, oral | 25MG | 12 Jan 2043 |
| 218808 · 002 · RLD | capsule, oral | 50MG | 12 Jan 2043 |
| 218808 · 003 · RLD | capsule, oral | 100MG | 12 Jan 2043 |
| 218820 · 001 · RLD | solution, oral | 50MG/ML | 12 Jan 2043 |