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.
MIRABEGRON | A209413 | AUROBINDO PHARMA LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Astellas Pharma Inc. et al v. Aurobindo Pharma Ltd. et al 1 patentANDA 209413, 209368, 209488, 209485mirabegron | D. Del. | 2021-03-24 | Active | — |
Astellas Pharma Inc. et al v. Sandoz Inc. et al 5 patentsANDA 209441, 209368, 209434, 209413, 209446, 209475, 209428, 209488, 209485mirabegron | D. Del. | 2020-11-24 | Terminated 2026-02-19 | — |
Astellas Pharma Inc. et al v. Aurobindo Pharma Ltd. et al 5 patentsANDA 209413mirabegron | D. Del. | 2016-10-13 | Terminated 2019-03-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.