Lupin has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg. The USFDA has approved the company’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 $70.7 million in the U.S. (IQVIA MAT Jul 2026).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
