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 SODIUM | A208355 | AUROBINDO PHARMA LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ViiV Healthcare Company et al v. Aurobindo Pharma Ltd. et al 1 patentANDA 208355dolutegravir sodium | D. Del. | 2025-10-30 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.