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.
PITOLISANT | A218873 | MSN LABORATORIES PRIVATE LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Harmony Biosciences, LLC et al v. MSN Pharmaceuticals Inc. et al 3 patentsANDA 218873pitolisant hydrochloride | D. Del. | 2023-12-11 | Terminated 2026-01-21 | — |
MSN Laboratories Private Limited v. Bioprojet Societe Civile De Recherche 3 patentsANDA 218873pitolisant hydrochloride | VAED | 2023-12-08 | Terminated 2024-01-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.