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.
LASMIDITAN | A219669 | HUMANWELL PHARMACEUTICAL US INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Eli Lilly & Company et al v. Humanwell Pharmaceutical US, Inc. et al 1 patentANDA 219669lasmiditan | MOED | 2025-03-21 | Terminated 2025-07-07 | — |
ELI LILLY & COMPANY et al v. HUMANWELL PHARMACEUTICAL US, INC. et al 1 patentANDA 219669lasmiditan | D.N.J. | 2025-03-21 | Terminated 2025-10-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.