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.
LIRAGLUTIDE | A213155 | MYLAN INSTITUTIONAL
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| WVND | 2019-08-22 | Terminated 2019-09-23 | — | |
| D. Del. | 2019-08-20 | Terminated 2021-04-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.