Lupin Wins Tentative U.S. FDA Nod for Generic Pitolisant Tablets

The latest announcement is out from Lupin Limited ( (IN:LUPIN) ).

Lupin Limited has secured tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths, which will be manufactured at its Nagpur facility in India. The tablets have been deemed bioequivalent to Wakix for the same approved indication, positioning Lupin to enter the U.S. market for this therapy once final approval and market conditions permit.

The move reinforces Lupin’s strategy of expanding its complex generics portfolio in the U.S., a key market where it already holds a strong presence across multiple therapeutic areas. By adding a bioequivalent version of Pitolisant, the company stands to broaden its central nervous system offerings and potentially capture share in a niche segment, which could support long-term growth and enhance its competitive stance in global generics.

More about Lupin Limited

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a presence in over 100 markets and a strong footprint in India and the U.S. The company develops branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients across major therapy areas, supported by 15 manufacturing sites, 7 research centers, and over 22,000 employees.

Lupin focuses on respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health therapies. Through subsidiaries such as Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions, it aims to enhance patient outcomes and expand its integrated healthcare offerings globally.

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