Treats excessive daytime sleepiness (EDS) or cataplexy. Sold as Wakix. Every FDA application for this active ingredient: 1 branded and 4 generic.
As of Nov 15, 2026, FDA lists 5 applications for Pitolisant Hydrochloride (sold as Wakix), first approved Oct 13, 2020, with 2 new uses approved and 1 published complete response letter.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Wakix | Part D | $171M | +29% | 1,610 |
| Oct 13, 2020 | WakixNDA 211150 · Efficacy (new indication or use) | Harmony | 4 | Marketed |
| Jul 21, 2026 | Pitolisant HydrochlorideANDA 218495 | Novitium Pharma | 0 | Marketed |
| Aug 14, 2026 | Pitolisant HydrochlorideANDA 218846 | Lupin | 0 | Marketed |
| Aug 14, 2026 | Pitolisant HydrochlorideANDA 218873 | Msn | 0 | Marketed |
| Oct 8, 2026 | Pitolisant HydrochlorideANDA 218832 | Annora Pharma | 0 | Marketed |
| Letter | Product | Now |
|---|---|---|
| Aug 14, 2019 | Wakix (pitolisant)Clinical, Harmony Ctp, Labeling | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Novitium Pharma
Lupin