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.
EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE | A214058 | CIPLA LIMITED
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Gilead Sciences, Inc. v. Apotex, Inc. et al 4 patentsANDA 213867, 214053, 214095, 214226, 213926, 214227, 214030, 213989, 214072, 213845, 214173, 214059, 214058, 214216, 214179, 211850tenofovir alafenamide | D. Del. | 2020-02-07 | Terminated 2022-09-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.