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Pitolisant Tablets

Narcolepsy

Approved (Tentative)Tentative FDA ApprovalN/A

Key Facts

Indication

Narcolepsy

Phase

Approved (Tentative)

Status

Tentative FDA Approval

Company

Lupin

About Lupin

Lupin is a mission-driven global pharmaceutical company focused on improving access to essential and advanced medicines through the development and commercialization of generic drugs, complex formulations, and biosimilars. Founded in 1968, it has grown into a top-tier generics player with a significant presence in the US, India, and other key markets, underpinned by robust R&D and manufacturing capabilities. Its strategy centers on expanding its complex generics and specialty portfolio, advancing its biosimilars pipeline, and leveraging operational excellence to drive sustainable, long-term growth.

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Therapeutic Areas

Multi-Therapeutic Metabolic Central Nervous System Gastroenterology Ophthalmology Respiratory

Other Narcolepsy Drugs

Drug	Company	Phase	Status
Pitolisant (Wakix®/Ozawade®)	Bioprojet SCR	Approved	Active
Sodium Oxybate (one-nightly)	D&A Pharma	Development	Active