Lupin gets USFDA approval for Modafinil tablets to treat excessive sleepiness

Pharmaceutical major Lupin on Friday announced that it has received approval from the United States Food and Drug Administration (USFDA) to market Modafinil tablets which are used to treat excessive sleepiness.

According to the company’s statement, it received approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP in 100 mg and 200 mg strengths.

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The approved drug is bioequivalent to the reference listed drug (RLD), Provigil Tablets of Nuvo Pharmaceuticals (Ireland) DAC, said the company.

The medication is used to improve wakefulness in adult patients, which is associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD), the release stated.

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The IQVIA MAT July 2026 data shows that Modafinil tablets had an estimated annual sales of USD 70.7 million in the United States.

The pharmaceutical company currently has 15 manufacturing facilities and has maintained its presence in more than 100 markets across the world.

(With inputs from PTI)