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Lupin receives US FDA approval for modafinil tablets

Published

5 September 2026

Topic

opportunities

Sectors

Drug Discovery

Geography

United States

Source

Read at pharmabiz.com

Verified

Fusion42 · 5 September 2026 · Fusion42 review

Lupin Limited received US FDA approval for its modafinil tablets USP, 100 mg and 200 mg, as bioequivalent to Provigil tablets by Nuvo Pharmaceuticals. The approval allows Lupin to market modafinil for excessive sleepiness conditions in the US, with Provigil's market valued at approximately USD 70.7 million annually.

This Wire brief sits within Fusion42's coverage of Drug Discovery, and 2 sources have reported it.

◆ The Wire takeaway

Your pharmaceutical company can now enter the US generic modafinil market, challenging an established $70 million product. This opens a clear path for patient access and revenue growth if you accelerate your US commercial launch plans.

Coverage

2 sources · 5 Sep 2026

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Topics

Drug Discoveryfda-approvalmodafinilgeneric-drugspharmaceuticalsus-market