Lupin receives FDA approval for Modafinil tablets in U.S

Lupin Limited, a global pharmaceutical leader headquartered in Mumbai, India, has achieved a significant milestone with the U.S. Food and Drug Administration (U.S. FDA) approving its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg. This approval is a testament to the company's commitment to expanding its presence in the U.S. market and enhancing its portfolio of pharmaceutical products.

The U.S. FDA has deemed Lupin's Modafinil Tablets USP, 100 mg and 200 mg bioequivalent to the reference listed drug (RLD), Provigil® Tablets, manufactured by Nuvo Pharmaceuticals (Ireland) DAC. This approval is particularly significant as it authorizes Lupin to market its Modafinil products in the U.S. for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD). According to IQVIA's latest data, Modafinil Tablets (RLD Provigil®) had estimated annual sales of USD 70.7 million in the U.S. during the fiscal period ending July 2026.

Lupin's successful submission and approval process underscores its capability to meet stringent regulatory standards and its dedication to delivering high-quality, innovative medicines to patients. This approval is expected to bolster Lupin's market position in the U.S. and further strengthen its presence in the pharmaceutical industry.

"Lupin is thrilled to receive this approval, which will allow us to offer a high-quality, bioequivalent alternative to patients in the U.S.," said Mr. Sanjay Jain, CEO of Lupin Limited. "This approval is a significant step in our strategy to expand our product offerings and meet the evolving healthcare needs of our patients."

Lupin's diversified portfolio, spanning generics, complex generics, specialty medicines, and biosimilars, continues to grow. The company's strong leadership in core therapeutic areas such as cardiovascular, respiratory, diabetes, gastrointestinal, and women's health, along with its state-of-the-art manufacturing facilities and robust research capabilities, positions it well for continued growth and innovation.

Provigil is a registered trademark of Nuvo Pharmaceuticals (Ireland) DAC.