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.
DOLUTEGRAVIR;RILPIVIRINE | A213120 | LUPIN LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ViiV Healthcare Company et al v. Lupin Limited et al 2 patentsANDA 213120Dolutegravir Sodium and Rilpivirine Hydrochloride | D. Del. | 2020-02-28 | Terminated 2022-03-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.