adagrasib · Bristol · NDA 216340
Krazati
Earliest generic entry, as listed
21 Aug 2043
Blocked by patent: US 12383503, US 12653789.
Listed patents · 5 unexpired
6 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12383503 | drug product · sets the listed date | 21 Aug 2043 |
| US 12653789 | drug product · sets the listed date | 21 Aug 2043 |
| US 12281113 | drug substance, drug product | 10 Sep 2041 |
| US 12336995 | use U-3953 | 5 Feb 2041 |
| US 10689377 | drug substance, drug product, use U-3490, U-3953 | 17 May 2037 |
| US 10689377 listing row | drug substance, drug product, use U-3490 | 17 May 2037 |
| US 10689377 listing row | drug substance, drug product, use U-3953 | 17 May 2037 |
Exclusivities · 2 unexpired
| ODE-352 | orphan drug (7 years) | 12 Dec 2029 |
| NCE | new chemical entity (5 years) | 12 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 |
|---|---|---|---|
| 216340 · 001 · RLD | tablet, oral | 200MG | 21 Aug 2043 |