CABOZANTINIB S-MALATE | N208692 | EXELIXIS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2025-00210 | 11298349 | IPR | Azurity Pharmaceuticals, Inc. | Institution Denied | 2024-11-18 | 2025-06-04 |
| IPR2025-00427 | 12128039 | IPR | Azurity Pharmaceuticals, Inc. | Discretionary Denial | 2025-01-09 | 2025-07-02 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-04-18 | Active | — | |
| D. Del. | 2025-04-11 | Terminated 2025-09-05 | — | |
Exelixis, Inc. v. Sun Pharmaceutical Industries Ltd. et al 1 patentANDA 214385cabozantinib | D. Del. | 2025-04-04 | Terminated 2025-12-30 | — |
Exelixis, Inc. v. MSN Laboratories Private Limited et al 1 patentANDA 213878cabozantinib | D. Del. | 2025-03-19 | Active | — |
| D. Del. | 2023-03-16 | Terminated 2024-07-09 | — | |
Exelixis, Inc. v. MSN Laboratories Private Limited et al 7 patentsANDA 213878cabozantinib | D. Del. | 2022-07-18 | Terminated 2024-10-23 | — |
Exelixis, Inc. v. Teva Pharmaceuticals Development, Inc., et al 3 patentsANDA 215942Cabozantinib | D. Del. | 2021-06-17 | Terminated 2023-09-19 | — |
Exelixis, Inc. v. MSN Laboratories Private Limited et al 1 patentANDA 213878cabozantinib | D. Del. | 2019-10-29 | Terminated 2023-01-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7579473 | Aug 14, 2026 | — | Yes | Yes | — | — |
| 8877776 | Oct 8, 2030 | — | Yes | Yes | — | |
| 9724342 | Jul 9, 2033 | — | — | Yes | — | — |
| 10034873 | Jul 18, 2031 | — | — | — | — | |
| 10039757 | Jul 18, 2031 | — | — | — | — | |
| 11091439 | Jan 15, 2030 | — | Yes | — | — | — |
| 11091440 | Jan 15, 2030 | — | — | Yes | — | — |
| 11098015 | Jan 15, 2030 | — | — | — | — | |
| 11298349 | Feb 10, 2032 | — | — | Yes | — | — |
| 12128039 | Feb 10, 2032 | — | — | Yes | — |
| Code | Date | Status |
|---|---|---|
| ODE-227 | Jan 14, 2026 | Expired |
| ODE-375 | Sep 17, 2028 | Active |
| ODE-530 | Mar 26, 2032 | Active |
Exelixis added an orphan drug exclusivity designation (ODE-530) to the NDA 208692 supplement 002 for Cabometyx (cabozantinib s-malate).
New: New record
New: New record
Orphan drug exclusivity was granted for Cabometyx (cabozantinib s-malate) under designation ODE-530, providing seven years of regulatory exclusivity protection.
New: New record