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 | A218846 | LUPIN LIMITED
| 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 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.