Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
BEMPEDOIC ACID, EZETIMIBE | A219421 | ALKEM LABORATORIES LIMITED
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ESPERION THERAPEUTICS, INC. v. ALKEM LABORATORIES LTD. 4 patentsANDA 219416, 219421Bempedoic acid; Bempedoic acid and Ezetimibe | D.N.J. | 2024-05-17 | Terminated 2026-02-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.