Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP

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MUMBAI, India and NAPLES, Fla., Sept. 4, 2026 /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg.

The U.S. FDA has approved Lupin's Modafinil Tablets USP, 100 mg and 200 mg as bioequivalent to the reference listed drug (RLD), Provigil® Tablets of Nuvo Pharmaceuticals (Ireland) DAC, and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD).

Modafinil Tablets (RLD Provigil®) had estimated annual sales of USD 70.7 million in the U.S. (IQVIA MAT Jul 2026).

About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. Lupin has a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, and continues to strengthen its market position through a differentiated portfolio. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. 15 state-of-the-art manufacturing facilities support sustainable operations, with 6 research centers and a dedicated workforce of over 26,000 professionals. Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company's business strategy.

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

*Safe Harbor Statement

Provigil is the registered trademark of Nuvo Pharmaceuticals (Ireland) DAC

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