Prescription medicine
Pitolisant Brand names: Wakix
Pitolisant (Wakix) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pitolisant FDA label on DailyMed (effective February 13, 2026, Harmony Biosciences, LLC); the NDA 211150 record on Drugs@FDA; every pitolisant label on DailyMed.
Highlights of the record
FDA label of February 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageWAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.
Forms and strengths
- 4.45 mg
- 17.8 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 14, 2019 Wakix, Harmony; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first July 21, 2026; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 7, 2030 Wakix tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,067 through July 30, 2026
What is pitolisant used for?
From the label: indications and usageWAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy patients 6 years of age and older with narcolepsy
FDA pharmacologic class: Histamine-3 Receptor Antagonist/Inverse Agonist.
Source: FDA drug label (Wakix), Harmony Biosciences, LLC, effective February 13, 2026 (SPL set 8daa5562-824e-476c-9652-26ceef3d4b0e), via openFDA; the full label on DailyMed
Is there a generic for pitolisant (Wakix)?
The FDA approved the first generic pitolisant on July 21, 2026. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 3 patents for Wakix tablets: the compound patent runs to March 7, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2026 first generic approved
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pitolisant?
The FDA Adverse Event Reporting System holds 2,067 reports that list pitolisant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 234 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Pitolisant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other