Lupin Gains US FDA Approval for Modafinil Tablets
Lupin Ltd has received US FDA approval for Modafinil Tablets USP in 100 mg and 200 mg strengths, with the products confirmed bioequivalent to Provigil Tablets, the reference drug of Nuvo Pharmaceuticals (Ireland) DAC. The medicine is indicated to improve wakefulness in adults experiencing excessive sleepiness linked to narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD).
As per IQVIA data cited by Lupin, the US market for Modafinil Tablets had estimated annual sales of $70.7 million based on July 2026 MAT, providing a relevant commercial opportunity for the product. Lupin’s Q1FY27 performance also remained strong, with net profit rising 16.1% YoY to ₹1,415 crore from ₹1,219 crore, while revenue increased 33.3% to ₹8,217 crore from ₹6,164 crore.
EBITDA grew 47.3% to ₹2,390 crore from ₹1,623 crore, taking the EBITDA margin to 29.1% from 26.3%, an expansion of 280 bps. US revenue increased to $366 million from $282 million, India sales rose 14% to ₹2,379.6 crore, developed-market revenue grew 48.3% to ₹1,149.4 crore and emerging-market revenue increased 51.7% to ₹989.7 crore.
R&D investment stood at ₹607.7 crore, or 7.4% of sales, while capital expenditure was ₹278.6 crore. Overall, the FDA approval adds another product opportunity in the US market while the quarterly numbers indicate broad-based operational growth across key geographies.