LUPIN : RECEIVES US FDA APPROVAL FOR MODAFINIL TABLETS

• Lupin receives approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg. • The tablets are bioequivalent to the reference listed drug, Provigil® Tablets of Nuvo Pharmaceuticals (Ireland) DAC. • Indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD). • The reference drug had estimated annual sales of USD 70.7 million in the U.S. (IQVIA MAT Jul 2026).

Lupin Limited

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