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.
FINGOLIMOD | A207940 | STANDARD CHEM AND PHARM CO LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation v. Accord Healthcare Inc. et al 1 patentANDA 207991, 208004, 207983, 207979, 210252, 207940, 208000, 207927, 207945, 207941, 207985, 207939Fingolimod | D. Del. | 2018-07-16 | Terminated 2022-10-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.