Lupin Limited has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, in 100 mg and 200 mg strengths. This approval allows Lupin to market generic versions of Provigil® Tablets, which are indicated for excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. The U.S. market for these tablets generated an estimated USD 70.7 million in annual sales as of July 2026.
FDA Approval for Modafinil Tablets USP
Lupin Limited announced on September 4, 2026, that it has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA). The approval is for Modafinil Tablets USP, available in 100 mg and 200 mg strengths.
Market Opportunity and Product Details
These approved Modafinil Tablets USP are bioequivalent to the reference listed drug, Provigil® Tablets by Nuvo Pharmaceuticals (Ireland) DAC. The medication is prescribed to improve wakefulness in adult patients experiencing excessive sleepiness due to conditions such as narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). The estimated annual sales for the reference product (Provigil®) in the U.S. market were USD 70.7 million as of July 2026, according to IQVIA data.
About Lupin Limited
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a strong international presence. The company operates in India, the U.S., other developed markets, and emerging markets, distributing its products in over 100 countries. Lupin’s diversified portfolio includes generics, complex generics, specialty medicines, and biosimilars. The company focuses on core therapeutic areas such as cardiovascular, respiratory, diabetes, gastrointestinal, and women’s health. Lupin has 15 state-of-the-art manufacturing facilities and 6 research centers, supported by a workforce of over 26,000 professionals. Sustainability is a key pillar of its business strategy.
Source: BSE
