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 | A219410 | CIPLA LIMITED
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 11 patentsANDA 219410olaparib | D.N.J. | 2025-01-09 | Terminated 2025-06-06 | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 7 patentsANDA 219410olaparib | D.N.J. | 2024-11-20 | Active | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 9 patentsANDA 219410olaparib | D.N.J. | 2024-07-31 | Active | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 5 patentsANDA 219410olaparib | D.N.J. | 2024-06-28 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.