Lupin Limited has informed the Exchange regarding a press release dated September 30, 2025, titled "Lupin Receives Approval from U.S. FDA for Rivaroxaban for Oral Suspension ".
LUPIN · price
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On the reaction day the stock moved 2.5 pts more than Nifty Midcap 150 and 2.3 pts more than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.
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Lupin has received approval from the U.S. FDA for its generic version of Rivaroxaban for Oral Suspension (1 mg/mL), bioequivalent to Janssen's Xarelto. The product is approved for pediatric use — treating blood clots in children and preventing clots after heart surgery. It will be made at Lupin's Chhatrapati Sambhajinagar plant in India. The addressable U.S. market is estimated at around USD 11 million annually (IQVIA MAT July 2025), making this a niche but portfolio-expanding addition. This is part of Lupin's ongoing strategy to widen its complex generic offerings in the U.S.
Mildly positive for the stock. The dollar opportunity is small (~$11M), so direct revenue impact is limited, but the approval strengthens Lupin's U.S. generic pipeline and showcases continued regulatory momentum.