pralsetinib · Rigel Pharms · NDA 213721
Gavreto
Earliest generic entry, as listed
19 Apr 2043
Blocked by patent: US 12692251.
Listed patents · 8 unexpired
9 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12692251 | drug product · sets the listed date | 19 Apr 2043 |
| US 12448366 | drug substance | 7 Jul 2042 |
| US 11273160 | use U-2952 | 3 Apr 2039 |
| US 11872192 | use U-2952 | 3 Apr 2039 |
| US 11963958 | use U-2828 | 3 Apr 2039 |
| US 12539303 | use U-2828 | 3 Apr 2039 |
| US 10030005 | drug substance, drug product, use U-2952, U-3002 | 1 Nov 2036 |
| US 10030005 listing row | drug substance, drug product, use U-2952 | 1 Nov 2036 |
| US 10030005 listing row | drug substance, drug product, use U-3002 | 1 Nov 2036 |
| US 12655128 | drug substance, drug product | 1 Nov 2036 |
Exclusivities · 3 unexpired
| ODE-340 | orphan drug (7 years) | 1 Dec 2027 |
| ODE-341 | orphan drug (7 years) | 1 Dec 2027 |
| ODE-318 | orphan drug (7 years) | 4 Sep 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 |
|---|---|---|---|
| 213721 · 001 · RLD | capsule, oral | 100MG | 19 Apr 2043 |