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.
LETROZOLE;RIBOCICLIB SUCCINATE | A215975 | MSN LABS PVT LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 2 patentsANDA 215975, 215976ribociclib | D. Del. | 2023-05-19 | Terminated 2025-02-04 | — |
Novartis Pharmaceuticals Corporation et al v. MSN Pharmaceuticals Inc. et al 5 patentsANDA 215975ribociclib and letrozole | D. Del. | 2021-07-01 | Terminated 2025-02-04 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.