Drug firm Lupin Ltd on Friday (September 4) said it has received United States Food and Drug Administration (US FDA) approval for Modafinil Tablets USP, 100 mg and 200 mg.
The US FDA has approved Lupin’s Modafinil Tablets as bioequivalent to Provigil Tablets, the reference listed drug of Nuvo Pharmaceuticals (Ireland) DAC.
Modafinil Tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD).
According to IQVIA data cited by Lupin, Modafinil Tablets, with Provigil as the reference listed drug, had estimated annual sales of $70.7 million in the US based on the July 2026 Moving Annual Total (MAT).Shares of Lupin Ltd ended at ₹2,111.00, down by ₹24.00, or 1.12%, on the BSE.
First Published: Sept 4, 2026 6:09 PM IST
