olutasidenib · Rigel Pharms · NDA 215814
Rezlidhia
Earliest generic entry, as listed
12 Nov 2039
Blocked by patent: US 11723905.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11723905 | drug product · sets the listed date | 12 Nov 2039 |
| US 11738018 | use U-3684 | 17 Jul 2039 |
| US 10532047 | drug substance | 16 May 2039 |
| US 10959994 | drug product | 16 May 2039 |
| US 11013733 | use U-3496 | 16 May 2039 |
| US 11013734 | use U-3495 | 16 May 2039 |
| US 11376246 | use U-3495 | 16 May 2039 |
| US 11497743 | use U-3495 | 16 May 2039 |
| US 12053463 | drug substance, drug product | 16 May 2039 |
| US 10414752 | drug product | 18 Sep 2035 |
| US 10550098 | drug product | 18 Sep 2035 |
| US 11498913 | drug product | 18 Sep 2035 |
| US 12275715 | drug substance, drug product, use U-3684 | 18 Sep 2035 |
| US 9834539 | drug substance, drug product, use U-3497 | 18 Sep 2035 |
Exclusivities · 2 unexpired
| ODE-413 | orphan drug (7 years) | 1 Dec 2029 |
| NCE | new chemical entity (5 years) | 1 Dec 2027 |
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 |
|---|---|---|---|
| 215814 · 001 · RLD | capsule, oral | 150MG | 12 Nov 2039 |