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.
Modafinil Tablets are bioequivalent to the reference listed drug (RLD), Provigil, of Nuvo Pharmaceuticals (Ireland) DAC. The drug is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea (OSA) or shift work disorder (SWD).
Provigil had estimated annual sales of USD 70.7 million in the US, according to IQVIA MAT July 2026.
The approval further strengthens Lupin’s portfolio of treatments for sleep disorders.
Last month, the company received final USFDA approval for its ANDA for Pitolisant Tablets, 4.45 mg and 17.8 mg. The product is bioequivalent to Harmony Biosciences’ Wakix and is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy, characterised by sudden loss of muscle strength, in patients aged six years and older with narcolepsy.
Narcolepsy is a chronic neurological sleep disorder that affects the brain’s ability to regulate sleep-wake cycles. It is characterised by excessive daytime sleepiness and sudden, uncontrollable episodes of falling asleep, often referred to as “sleep attacks.”
People with narcolepsy may also experience muscle weakness (cataplexy), vivid dreams and temporary paralysis when falling asleep or waking up. Although narcolepsy is relatively uncommon and has no cure, medications and lifestyle changes can help manage symptoms and improve quality of life.
