Regulatory Approval Disclosure
Lupin Limited announced 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.
Product Details
The U.S. FDA approved Lupin's Modafinil Tablets USP as bioequivalent to the reference listed drug (RLD), Provigil® Tablets of Nuvo Pharmaceuticals (Ireland) DAC. The product is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Market Context
Modafinil Tablets (RLD Provigil®) had estimated annual sales of USD 70.7 million in the U.S. based on IQVIA MAT data for July 2026.
Company Background
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with presence across India, the U.S., Other Developed Markets, and Emerging Markets. The company's products are distributed in over 100 markets. Lupin maintains a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, with strong leadership in the U.S. and India across therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. The company operates 15 manufacturing facilities and 6 research centers with over 26,000 professionals.
Legal Disclaimer
Provigil is registered trademark of Nuvo Pharmaceuticals (Ireland) DAC.