Lupin gets USFDA tentative approval for Siponimod Tablets

Regulatory product approvalBusiness Updates View source PDF Explain this filing

LUPIN · price

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₹2088.00

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Nifty Midcap 150market · index membership as recorded later (tracked since Jun 2026)+0.4%-0.3% vs market

Pharmaceuticals peers, median of 156sector-0.3%+0.4% vs sector

On the reaction day the stock moved 0.3 pts less than Nifty Midcap 150 and 0.4 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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AI summary

Lupin has received tentative approval from U.S. FDA for its generic Siponimod Tablets (0.25mg, 1mg, 2mg), used to treat multiple sclerosis. The drug is a generic of Novartis's Mayzent, which had estimated U.S. annual sales of USD 195 million. Tablets will be made at Lupin's Pithampur facility in India.

Likely market impact

Paves way for Lupin to launch a U.S. generic once Novartis exclusivity ends, tapping a USD 195 million market opportunity.