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.
LENVATINIB MESYLATE | A213092 | SUN PHARM INDS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
EISAI R&D MANAGEMENT CO., LTD. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 2 patentsANDA 213092lenvatinib mesylate | D.N.J. | 2019-12-23 | Terminated 2020-03-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.