Lupin shares rose as much as 2% intraday, touching a high of Rs 2,135.50, after the USFDA approved its modafinil tablets.

The USFDA has cleared Lupin’s Abbreviated New Drug Application, or ANDA, for modafinil tablets in two strengths, 100 mg and 200 mg.

This is a generic version of Provigil, a drug made by Nuvo Pharmaceuticals that’s used to help adults stay awake when they struggle with excessive sleepiness.

That condition typically shows up in people with narcolepsy, obstructive sleep apnea, or those dealing with irregular shift work schedules.

The regulator confirmed that Lupin’s version works the same way in the body as the original branded drug, which is what allows it to be sold as an interchangeable generic in the US market.

For context on the size of the opportunity, modafinil tablets sold under the Provigil brand brought in close to $70.7 million in annual US sales, based on IQVIA data through July 2026. This isn’t Lupin’s only regulatory move in recent weeks.

The company had earlier informed the exchange about an ESG rating update on August 28, and separately intimated an allotment of equity shares under its employee stock option scheme on August 25.

Lupin continues to expand its US generics pipeline steadily, with ANDA approvals forming a regular part of its disclosures to investors.

Lupin is one of India’s larger pharmaceutical companies, with a strong presence in generics, complex generics, and specialty products across the US, India, and other global markets.

The company’s approvals pipeline with the USFDA has remained active through the year, adding incrementally to its addressable product basket in the US.

As of 11:33 am on Monday, the stock was trading at ₹2,116.20 on the NSE, up 0.29% for the day.

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