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.
VILOXAZINE HYDROCHLORIDE | A220326 | APPCO PHARMA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Supernus Pharmaceuticals, Inc. v. Appco Pharma LLC et al 6 patentsANDA 220326viloxazine extended-release | D. Del. | 2025-07-01 | Terminated 2025-09-30 | — |
SUPERNUS PHARMACEUTICALS, INC. v. APPCO PHARMA LLC et al 6 patentsANDA 220326viloxazine extended-release | D.N.J. | 2025-06-26 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.