LUMATEPERONE TOSYLATE | N209500 | INTRA-CELLULAR THERAPIES INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
INTRA-CELLULAR THERAPIES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC. et al 14 patentsANDA 218652lumateperone | D.N.J. | 2025-01-31 | Active | — |
| D.N.J. | 2024-11-01 | Terminated 2025-01-10 | — | |
| D.N.J. | 2024-08-29 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE48825 | Mar 12, 2029 | — | Yes | Yes | — | — |
| RE48839 | Aug 19, 2033 | — | — | — | — | |
| 8598119 | Dec 28, 2029 | — | — | — | Delisted | |
| 8648077 | Dec 1, 2029 | — | Yes | Yes | — | — |
| 9199995 | Mar 12, 2029 | — | — | — | — | |
| 9586960 | Mar 12, 2029 | — | Yes | Yes | — | — |
| 9616061 | May 27, 2029 | — | — | Yes | — | — |
| 9956227 | Dec 3, 2034 | — | — | — | — | |
| 10117867 | May 27, 2029 | — | — | — | — | |
| 10464938 | Mar 12, 2028 | — | — | Yes | — | — |
| 10695345 | Aug 30, 2039 | — | — | Yes | — | |
| 10960009 | Dec 3, 2034 | — | — | — | — | |
| 11026951 | Dec 3, 2034 | — | — | — | — | |
| 11690842 | Aug 30, 2039 | — | — | Yes | — | |
| 11753419 | Dec 10, 2040 | — | — | Yes | — | Delisted |
| 11806348 | Aug 30, 2039 | — | — | Yes | — | |
| 11980617 | Oct 27, 2039 | — | — | — | — | |
| 12070459 | Aug 30, 2039 | — | — | Yes | — | |
| 12090155 | Jul 7, 2040 | — | — | Yes | — | |
| 12122792 | Dec 10, 2040 | — | — | Yes | — | |
| 12128043 | Aug 30, 2039 | — | — | Yes | — | |
| 12409176 | Mar 15, 2039 | — | — | — | — | |
| 12410195 | Dec 10, 2040 | — | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| I-904 | Nov 5, 2028 | Active |
| M-319 | Apr 24, 2029 | Active |
Intra-Cellular gained pediatric exclusivity for Caplyta (lumateperone tosylate) under exclusivity code M-319, extending regulatory exclusivity protection.
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