RIBOCICLIB SUCCINATE | N209092 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation et al v. Alembic Pharmaceuticals Ltd. et al 5 patentsANDA 215676, 215677ribociclib | D. Del. | 2025-03-20 | Terminated 2025-03-28 | — |
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 2 patentsANDA 215976ribociclib | D. Del. | 2024-10-24 | Terminated 2025-02-04 | — |
Novartis Pharmaceuticals Corporation et al v. Natco Pharma Limited et al 2 patentsANDA 219528ribociclib | D. Del. | 2024-09-13 | Terminated 2025-05-01 | — |
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 2 patentsANDA 215975, 215976ribociclib | D. Del. | 2023-05-19 | Terminated 2025-02-04 | — |
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 5 patentsANDA 215976ribociclib | D. Del. | 2021-07-29 | Terminated 2025-02-04 | — |
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 8 patentsANDA 214746, 214771ribociclib | D. Del. | 2021-06-17 | Terminated 2025-02-04 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8324225 | Jun 17, 2028PED: Dec 17, 2028 | PED | Yes | Yes | — | — |
| 8415355 | Mar 13, 2031PED: Sep 13, 2031 | PED | Yes | Yes | — | — |
| 8685980 | May 25, 2030PED: Nov 25, 2030 | PED | Yes | Yes | — | — |
| 8962630 | Dec 9, 2029PED: Jun 9, 2030 | PED | — | — | — | |
| 9193732 | Nov 9, 2031PED: May 9, 2032 | PED | Yes | Yes | — | — |
| 9416136 | Aug 20, 2029PED: Feb 20, 2030 | PED | — | — | — | |
| 9868739 | Nov 9, 2031PED: May 9, 2032 | PED | — | — | — | |
| 10799506 | Apr 14, 2036PED: Oct 14, 2036 | PED | — | Yes | — | — |
| 12064434 | Apr 14, 2036PED: Oct 14, 2036 | PED | — | Yes | — | — |
| 12419894 | Apr 14, 2036PED: Oct 14, 2036 | PED | — | Yes | — | — |
| 12544379 | Aug 7, 2034PED: Feb 7, 2035 | PED | — | — | — | |
| 12544380 | Aug 7, 2034PED: Feb 7, 2035 | PED | — | — | — |
| Code | Date | Status |
|---|---|---|
| I-950 | Sep 17, 2027 | Active |
| PED | Mar 17, 2028 | Active |
Novartis added U.S. patent 12544380 (pediatric exclusivity) to the Orange Book listing for Kisqali (ribociclib succinate).
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Novartis added U.S. Patent 8,685,980 (pediatric exclusivity) to the Orange Book listing for Kisqali (ribociclib succinate).
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Novartis listed U.S. Patent 8,324,225 (with pediatric exclusivity designation) in the Orange Book for Kisqali (ribociclib succinate).
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Novartis listed U.S. Patent No. 10,799,506 for ribociclib succinate (Kisqali) in the Orange Book; patent expiration date is Apr 2041.
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Novartis added U.S. Patent 12,419,894 (pediatric exclusivity extension) to the Orange Book for Kisqali (ribociclib succinate), NDA 209092.
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Novartis listed U.S. Patent 12,544,379 (pediatric exclusivity designation) in the Orange Book for KISQALI (ribociclib succinate).
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Novartis added U.S. Patent 8,962,630 (pediatric exclusivity code PED) to the Orange Book listing for Kisqali (ribociclib succinate), NDA 209092.
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Novartis listed U.S. Patent 8,415,355 (with pediatric exclusivity designation) for ribociclib succinate (KISQALI, NDA 209092) in the Orange Book.
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Novartis added U.S. Patent 9,868,739 (pediatric exclusivity) to the Orange Book for Kisqali (ribociclib succinate) NDA 209092.
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Novartis listed patent 12064434 (pediatric exclusivity designation) for Kisqali (ribociclib succinate) in the Orange Book.
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KISQALI (ribociclib succinate) added patent '9416136' with pediatric exclusivity designation to Orange Book for NDA 209092.
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Novartis added U.S. Patent 9,193,732 (with pediatric exclusivity) to the Orange Book listing for Kisqali (ribociclib succinate) NDA 209092.
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