cabozantinib s-malate · Exelixis Inc · NDA 208692
Cabometyx
Blocked by patent: US 9724342.
FDA has approved 2 generic applications (ANDAs) for Cabometyx, though its earliest generic-entry date is 9 Jul 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 9 unexpired
19 Orange Book listing rows for 9 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9724342 | drug product · sets the listed date | 9 Jul 2033 |
| US 11298349 | drug product | 10 Feb 2032 |
| US 12128039 | drug product, use U-1220, U-1480, U-2488, U-3225, U-4131, U-4156 | 10 Feb 2032 |
| US 12128039 listing row | drug product, use U-1220 | 10 Feb 2032 |
| US 12128039 listing row | drug product, use U-1480 | 10 Feb 2032 |
| US 12128039 listing row | drug product, use U-2488 | 10 Feb 2032 |
| US 12128039 listing row | drug product, use U-3225 | 10 Feb 2032 |
| US 12128039 listing row | drug product, use U-4131 | 10 Feb 2032 |
| US 12128039 listing row | drug product, use U-4156 | 10 Feb 2032 |
| US 10034873 | use U-2488 | 18 Jul 2031 |
| US 10039757 | use U-1480 | 18 Jul 2031 |
| US 8877776 | drug substance, drug product, use U-3225 | 8 Oct 2030 |
| US 11091439 | drug substance | 15 Jan 2030 |
| US 11091440 | drug product | 15 Jan 2030 |
| US 11098015 | use U-1220, U-1480, U-2488, U-3225, U-4131, U-4156 | 15 Jan 2030 |
| US 11098015 listing row | use U-1220 | 15 Jan 2030 |
| US 11098015 listing row | use U-1480 | 15 Jan 2030 |
| US 11098015 listing row | use U-2488 | 15 Jan 2030 |
| US 11098015 listing row | use U-3225 | 15 Jan 2030 |
| US 11098015 listing row | use U-4131 | 15 Jan 2030 |
| US 11098015 listing row | use U-4156 | 15 Jan 2030 |
Exclusivities · 2 unexpired
| ODE-530 | orphan drug (7 years) | 26 Mar 2032 |
| ODE-375 | orphan drug (7 years) | 17 Sep 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
- First generic approved · ANDA 213878, Msn · 208692-001Approved 14 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 213878, Msn · 208692-001Approved 14 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217870, Cipla · 208692-001Approved 16 Oct 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208692 · 001 · RLD | tablet, oral | EQ 20MG BASE | 9 Jul 2033 |
| 208692 · 002 · RLD | tablet, oral | EQ 40MG BASE | 9 Jul 2033 |
| 208692 · 003 · RLD | tablet, oral | EQ 60MG BASE | 9 Jul 2033 |
Expired or delisted (2)
- US 7579473 · substance, product · 14 Aug 2026
- ODE-227 · 14 Jan 2026