nilotinib · Cycle · NDA 217379
Cavhanza
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Apr 2041
Blocked by patent: US 11559485.
Listed patents · 4 unexpired
6 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11559485 | drug product · sets the listed date | 30 Apr 2041 |
| US 11389450 | use U-4556, U-4557 | 29 Jan 2041 |
| US 11389450 listing row | use U-4556 | 29 Jan 2041 |
| US 11389450 listing row | use U-4557 | 29 Jan 2041 |
| US 12016861 | use U-4554, U-4555 | 29 Jan 2041 |
| US 12016861 listing row | use U-4554 | 29 Jan 2041 |
| US 12016861 listing row | use U-4555 | 29 Jan 2041 |
| US 12029740 | drug product | 29 Jan 2041 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217379 · 001 · RLD | tablet, orally disintegrating, oral | 60MG | 30 Apr 2041 |
| 217379 · 002 · RLD | tablet, orally disintegrating, oral | 80MG | 30 Apr 2041 |