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 | — | |
INTRA-CELLULAR THERAPIES, INC. v. ALKEM LABORATORIES LTD. 2 patentsANDA 219200lumateperone | D.N.J. | 2024-08-29 | Active | — |
INTRA-CELLULAR THERAPIES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC. et al 7 patentsANDA 218652lumateperone | D.N.J. | 2024-08-29 | Active | — |
| D.N.J. | 2024-08-29 | Active | — | |
| D.N.J. | 2024-03-27 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
Highest NADAC/Unit
$57.29
per ea
Lowest NADAC/Unit
$57.26
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 72060011040CAPLYTA 10.5 MG CAPSULE | $57.29 | EA | Brand | — | 2026-06-17 |
| 72060014240CAPLYTA 42 MG CAPSULE | $57.27 | EA | Brand | — | 2026-06-17 |
| 72060012140CAPLYTA 21 MG CAPSULE | $57.26 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| 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 |