Lupin Gains FDA Approval for Pitolisant Tablets to Treat Narcolepsy

In Brief

1. Final U.S. FDA ANDA approval granted to Lupin for generic Pitolisant Tablets.
2. Approved in two specific strengths: 4.45 mg and 17.8 mg.
3. Bioequivalent generic version of Harmony Biosciences’ reference drug Wakix.
4. Treats narcolepsy symptoms, specifically excessive daytime sleepiness (EDS) and cataplexy, in patients 6 years and older.
5. Strengthens Lupin’s CNS portfolio and expands its commercial presence in the U.S. generic pharmaceutical market.

Lupin has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths. The FDA approved Lupin’s generic as bioequivalent to Harmony Biosciences’ Wakix, a prescription medicine used to treat excessive daytime sleepiness (EDS) or cataplexy in patients aged 6 years and older with narcolepsy.

This clearance allows Lupin to expand its U.S. product portfolio within the specialized Central Nervous System (CNS) treatment segment. Pitolisant targets key symptoms of narcolepsy by addressing daytime drowsiness and sudden muscle weakness (cataplexy), marking another significant regulatory milestone for Lupin in its key U.S. market.