Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
SOLRIAMFETOL HYDROCHLORIDE | A218722 | ALKEM LABS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2025-11-12 | Terminated 2026-02-19 | — | |
| D.N.J. | 2025-08-15 | Terminated 2026-02-19 | — | |
AXSOME MALTA LTD. et al v. ALKEM LABORATORIES LTD. et al 13 patentsANDA 218722, 218725, 218654, 218016, 218610, 218761solriamfetol | D.N.J. | 2023-09-13 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.