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.
IBRUTINIB | A212763 | ALVOGEN PINE BROOK
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Pharmacyclics LLC et al v. Alvogen Pine Brook, LLC et al 1 patentANDA 211319, 211344, 211267, 212763ibrutinib | D. Del. | 2020-03-20 | Terminated 2021-04-13 | — |
| D. Del. | 2019-03-01 | Terminated 2021-08-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.