Lupin Wins FDA Approval for Modafinil Tablets in U.S.

Mumbai, India, and Naples, Florida, USA, September 4, 2026

FDA Approval Expands Lupin’s Modafinil Portfolio

The approval represents another regulatory milestone for Lupin’s U.S. generics business, particularly in the area of medicines used to manage sleep-related disorders. Modafinil is a wakefulness-promoting medicine used in adults experiencing excessive daytime sleepiness associated with narcolepsy, OSA, and shift work disorder. Under the FDA approval, Lupin’s 100 mg and 200 mg tablets are considered bioequivalent to the reference listed drug, supporting their regulatory pathway as generic equivalents of the branded product. The approval was granted following Lupin’s ANDA submission and adds another FDA-approved product to the company’s U.S. pharmaceutical portfolio. According to Lupin, the reference product Provigil Tablets had estimated annual U.S. sales of approximately $70.7 million, based on IQVIA MAT July 2026 data. The commercial opportunity associated with the approval therefore adds to Lupin’s presence in the U.S. market for established pharmaceutical therapies. While the approval enables Lupin to market its generic product, the company’s announcement does not claim new clinical efficacy for modafinil; instead, the regulatory milestone is based on the product’s demonstrated bioequivalence to the reference medicine.

Modafinil Targets Excessive Daytime Sleepiness

The newly approved Modafinil Tablets USP are intended for adult patients whose excessive sleepiness is associated with three recognized conditions. Narcolepsy is a neurological disorder characterized by excessive daytime sleepiness and abnormal regulation of sleep and wakefulness. In patients with obstructive sleep apnea, excessive sleepiness can persist despite treatment of the underlying airway obstruction. Shift work disorder can also cause excessive sleepiness when work schedules conflict with normal circadian sleep patterns. Modafinil’s approved use in these settings is focused on promoting wakefulness, rather than treating the underlying causes of these disorders. The approval covers two tablet strengths, 100 mg and 200 mg, giving healthcare providers the same dosage-strength options represented by the approved generic product. As with other FDA-approved medicines, the product’s use is governed by its approved prescribing information, including applicable safety, dosing, contraindication, and monitoring considerations.

Lupin Strengthens U.S. Generic Drug Presence

The FDA decision further supports Lupin’s strategy of expanding its generic and complex pharmaceutical portfolio across major international markets. Lupin operates across India, the United States, other developed markets and emerging markets, with products distributed in more than 100 countries. The company maintains a diversified portfolio covering generics, complex generics, specialty medicines and biosimilars, supported by research and manufacturing infrastructure. Lupin reports operating 15 manufacturing facilities and six research centers, with a workforce of more than 26,000 professionals. The modafinil approval follows several other recent U.S. regulatory milestones for Lupin, including FDA approvals for pitolisant tablets, sodium zirconium cyclosilicate for oral suspension, diazepam injection and sugammadex injection. These approvals demonstrate the company’s continued focus on expanding its U.S. product pipeline across multiple therapeutic and dosage-form segments. The latest authorization therefore strengthens Lupin’s position in the U.S. generic medicines market while providing another FDA-approved treatment option for adults experiencing excessive sleepiness associated with specific sleep and work-schedule disorders. The milestone also highlights the continuing role of bioequivalent generic medicines in expanding access to established pharmaceutical therapies.

Source: Lupin press release