Not in the current Orange Book— This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
PITOLISANT HYDROCHLORIDE | A218846 | LUPIN
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Harmony Biosciences Management, Inc. et al v. Lupin Limited et al 2 patentsANDA 218846pitolisant hydrochloride | D. Del. | 2025-01-24 | Terminated 2025-06-11 | — |
Harmony Biosciences, LLC et al v. Lupin Limited et al 2 patentsANDA 218846, 218834pitolisant hydrochloride | D. Del. | 2023-11-09 | Terminated 2024-02-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.