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.
UBROGEPANT | A218662 | ZYDUS PHARMACEUTICALS (USA) INC.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ABBVIE INC. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 8 patentsANDA 218662ubrogepant | D.N.J. | 2024-04-05 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.