India Pharma Outlook Team | Wednesday, 25 March 2026
Lupin has secured US FDA approval for Pitolisant tablets ANDA, marking another step in its push into the central nervous system segment.
The approval covers Pitolisant Tablets in strengths of 4.45 mg and 17.8 mg, a generic version of Wakix, used to treat excessive daytime sleepiness in narcolepsy patients.
Pitolisant is prescribed for adults and children aged six years and above suffering from narcolepsy. It is also used in adults to manage cataplexy, a condition that causes sudden muscle weakness. The drug works as an H3 receptor antagonist, helping regulate neurotransmitters that control the sleep-wake cycle. With this US FDA tentative approval for Pitolisant tablets ANDA, Lupin moves closer to offering a cost-effective alternative in the U.S. market.
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The company confirmed that its product is bioequivalent to Wakix, meeting all regulatory standards set by the U.S. Food and Drug Administration. Manufacturing will take place at Lupin’s Nagpur facility, which is part of its global network of 15 manufacturing sites.
Lupin continues to strengthen its position as a global pharmaceutical player, with operations in over 100 markets and a portfolio spanning branded and generic drugs, complex generics, biotechnology products, and APIs.
On the financial front, the company reported strong growth. Consolidated net profit jumped 37.46% year-on-year to Rs 1,175.55 crore in Q3 FY26, compared to Rs 855.16 crore in the same quarter last year. Revenue from operations rose 24.26% to Rs 7,167.52 crore for the quarter ended December 31, 2025. This regulatory update was disclosed under SEBI norms, ensuring transparency for investors and stakeholders.
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