WAKIX

Peak

pitolisant hydrochloride

Harmony Biosciences

NDAORALTABLETPriority Review

Approved

Aug 2019

Lifecycle

Peak

Competitive Pressure

8/100

Clinical Trials

1

Clinical Trials (1)

NCT05536011N/ARecruiting

WAKIX® (Pitolisant) Pregnancy Registry

Started Aug 2021

1,329 enrolled

Pregnancy RelatedNarcolepsy

Loss of Exclusivity

LOE Date

Mar 7, 2030

48 months away

Patent Expiry

Mar 7, 2030

Exclusivity Expiry

Jun 21, 2031

Patent Records (3)

Patent #	Expiry	Type	Use Code
8354430	Feb 6, 2026Expired		U-1102
8486947	Sep 26, 2029		U-1102
8207197	Mar 7, 2030	SubstanceProduct	—

Company

Harmony Biosciences

PLYMOUTH MEETING, PA

External Resources

Full prescribing information

FDA approval history

Drug nomenclature & identifiers