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.
OLAPARIB | A219893 | ZYDUS PHARMS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTRAZENECA PHARMACEUTICALS LP et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 10 patentsANDA 219893olaparib | D.N.J. | 2025-01-09 | Terminated 2025-06-06 | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 1 patentANDA 219893olaparib | D.N.J. | 2024-11-12 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.