cabozantinib laurylsulfate · Handa Oncol · NDA 220613
Omcazio
Earliest generic entry, as listed · earliest of 3 marketed strengths
30 Jan 2044
Blocked by patent: US 12415784, US 12516025, US 12552567, US 12552749, US 12741938.
Listed patents · 6 unexpired
13 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12415784 | — · sets the listed date | 30 Jan 2044 |
| US 12516025 | use U-1480, U-2488, U-4131 | 30 Jan 2044 |
| US 12516025 listing row | use U-1480 · sets the listed date | 30 Jan 2044 |
| US 12516025 listing row | use U-2488 · sets the listed date | 30 Jan 2044 |
| US 12516025 listing row | use U-4131 · sets the listed date | 30 Jan 2044 |
| US 12552567 | use U-1480, U-2488, U-4131 | 30 Jan 2044 |
| US 12552567 listing row | use U-1480 · sets the listed date | 30 Jan 2044 |
| US 12552567 listing row | use U-2488 · sets the listed date | 30 Jan 2044 |
| US 12552567 listing row | use U-4131 · sets the listed date | 30 Jan 2044 |
| US 12552749 | use U-1480, U-2488, U-4131 | 30 Jan 2044 |
| US 12552749 listing row | use U-1480 · sets the listed date | 30 Jan 2044 |
| US 12552749 listing row | use U-2488 · sets the listed date | 30 Jan 2044 |
| US 12552749 listing row | use U-4131 · sets the listed date | 30 Jan 2044 |
| US 12741938 | drug product · sets the listed date | 30 Jan 2044 |
| US 12064430 | use U-1480, U-2488 | 13 Jun 2039 |
| US 12064430 listing row | use U-1480 | 13 Jun 2039 |
| US 12064430 listing row | use U-2488 | 13 Jun 2039 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 220613 · 001 · RLD | capsule, oral | EQ 11.5MG BASE | 30 Jan 2044 |
| 220613 · 002 · RLD | capsule, oral | EQ 23MG BASE | 30 Jan 2044 |
| 220613 · 003 · RLD | capsule, oral | EQ 34.5MG BASE | 30 Jan 2044 |