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.
LUTETIUM LU-177 DOTATATE | N218525 | CURIUM
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Advanced Accelerator Applications USA, Inc. et al v. Curium US LLC et al 4 patentslutetium Lu 177 dotatate | D. Del. | 2025-09-16 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.