Lupin Limited announced that it has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP in 100 mg and 200 mg strengths.
Lupin’s Modafinil Tablets USP are the bioequivalent generic alternative to the reference listed drug (RLD), Provigil® Tablets, of Nuvo Pharmaceuticals (Ireland) DAC. The medication is indicated to improve wakefulness in adult patients experiencing excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
According to IQVIA MAT July 2026 data, Modafinil Tablets (RLD Provigil®) had estimated annual sales of approximately USD 70.7 million in the United States.
The approval further strengthens Lupin’s growing central nervous system (CNS) portfolio in the United States, expanding patient access to high-quality, affordable therapies for chronic sleep and neurological disorders.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
