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.
SAFINAMIDE | A216020 | OPTIMUS PHARMA PRIVATE LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Newron Pharmaceuticals S.p.A et al v. MSN Laboratories Private Limited et al 3 patentsANDA 215902, 215978, 216020, 215739, 215945, 215913safinamide | D. Del. | 2021-06-10 | Terminated 2023-11-22 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.