Lupin receives U.S. FDA approval for Modafinil Tablets, USP
Lupin Limited received U.S. FDA approval for Modafinil Tablets USP, 100 mg and 200 mg. The drug is indicated to improve wakefulness in adult patients with narcolepsy, OSA, or SWD. The RLD, Provigil®, had estimated annual U.S. sales of USD 70.7 million (approx. ₹590 crore).
FDA approvals are significant for pharmaceutical companies. The estimated annual sales of the reference drug suggest a notable market opportunity, impacting Lupin's revenue.
The U.S. FDA approval for a new drug product is a positive development for the company, potentially leading to increased revenue and market share.
Lupin Limited has 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. These tablets are 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 (approximately ₹590 crore) in the U.S. as of July 2026.
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