Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets in strengths of 4.45 mg and 17.8 mg.

The approved formulation is therapeutically equivalent to Wakix, a treatment indicated for specific central nervous system (CNS) conditions as per the reference listed drug’s labeling. The product will be manufactured at Lupin’s Nagpur facility, reinforcing the company’s domestic manufacturing capabilities aligned with global regulatory standards.

Tentative approval from the U.S. FDA indicates that Lupin’s product meets the required safety, efficacy, and quality benchmarks. However, final approval will be subject to the expiration of any existing patent or exclusivity protections associated with the reference drug.

This development marks another step in Lupin’s strategy to strengthen its presence in the U.S. generics market, particularly within the CNS therapeutic segment. The company continues to focus on expanding its portfolio of complex generics and differentiated products to address evolving patient needs and market opportunities.

Headquartered in Mumbai, Lupin operates across more than 100 markets and maintains a diversified portfolio spanning branded and generic formulations, biotechnology products, and active pharmaceutical ingredients. With a robust network of manufacturing facilities and research centers globally, the company remains committed to advancing accessible and high-quality healthcare solutions.

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The tentative approval also underscores the growing role of Indian pharmaceutical manufacturers in supplying cost-effective alternatives to the U.S. healthcare system, while maintaining compliance with stringent regulatory frameworks.

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