crizotinib · Pf Prism Cv · NDA 202570, 217581
Xalkori
Earliest generic entry, as listed · earliest of 5 marketed strengths
6 Nov 2029
Blocked by patent: US 8217057.
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8217057 | drug substance, drug product · sets the listed date | 6 Nov 2029 |
| US 7858643 | drug substance, drug product | 8 Oct 2029 |
| US 7825137 | use U-3057, U-3058, U-3403 | 12 May 2027 |
| US 7825137 listing row | use U-3057 | 12 May 2027 |
| US 7825137 listing row | use U-3058 | 12 May 2027 |
| US 7825137 listing row | use U-3403 | 12 May 2027 |
Exclusivities · 2 unexpired
| ODE-407 | orphan drug (7 years) | 14 Jul 2029 |
| ODE-328 | orphan drug (7 years) | 14 Jan 2028 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202570 · 001 · RLD | capsule, oral | 200MG | 6 Nov 2029 |
| 202570 · 002 · RLD | capsule, oral | 250MG | 6 Nov 2029 |
| 217581 · 001 · RLD | capsule, pellets, oral | 20MG | 6 Nov 2029 |
| 217581 · 002 · RLD | capsule, pellets, oral | 50MG | 6 Nov 2029 |
| 217581 · 003 · RLD | capsule, pellets, oral | 150MG | 6 Nov 2029 |