Lupin: USFDA Approval for Modafinil Tablets

is in focus after receiving approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Modafinil Tablets USP in 100 mg and 200 mg strengths. The tablets are bioequivalent to Provigil Tablets, the reference listed drug, and are indicated to improve wakefulness in adults suffering from excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder. According to IQVIA data, the U.S. market for the reference product recorded estimated annual sales of approximately $70.7 million for the 12 months ended July 2026. The approval adds another product to Lupin’s U.S. pharmaceutical portfolio and provides the company with an opportunity to participate in this market following regulatory clearance. Lupin shares were trading marginally lower in early trade despite the approval, with the stock quoted around ₹2,106 at 9:27 a.m. on September 7. Investors will now track the commercial launch of the product and its contribution to Lupin’s U.S. business.