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.
RIVAROXABAN | A212220 | MYLAN PHARMS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GMBH et al 2 patentsANDA 212220rivaroxaban | D. Del. | 2023-05-19 | Terminated 2024-03-14 | — |
Bayer Pharma AG et al v. Mylan Pharmaceuticals Inc. et al 1 patentANDA 212220rivaroxaban | WVND | 2021-07-22 | Terminated 2021-12-10 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.