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.
BRINZOLAMIDE;BRIMONIDINE TARTRATE | A212137 | PERRIGO PHARMA INTERNATIONAL DAC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Alcon Inc. et al v. Padagis Israel Pharmaceuticals Ltd. et al 2 patentsANDA 212137brinzolamide/brimonidine tartrate | D. Del. | 2022-10-27 | Terminated 2025-02-11 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.