sebetralstat · Kalvista · NDA 219301
Ekterly
Earliest generic entry, as listed
26 Jan 2039
Blocked by patent: US 11234939.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11234939 | product, use U-4223 | 26 Jan 2039 |
| US 11230537 | substance, product | 25 Dec 2037 |
| US 11739068 | use U-4223 | 23 Jun 2037 |
| US 10364238 | substance, product | 26 Nov 2035 |
| US 10611758 | use U-4223 | 26 Nov 2035 |
| US 11001578 | substance, product | 26 Nov 2035 |
| US 11084809 | substance, product, use U-4223 | 26 Nov 2035 |
| US 11198691 | use U-4223 | 26 Nov 2035 |
Exclusivities · 2 unexpired
| ODE-534 | orphan drug (7 years) | 3 Jul 2032 |
| NCE | new chemical entity (5 years) | 3 Jul 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 |
|---|---|---|---|
| 219301 · 001 · RLD | tablet, oral | 300MG | 26 Jan 2039 |