Lupin gets US FDA approval for Pitolisant Tablets generic

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

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Price reactionminutes from the announcement price · days from the prior close

+1.1%Reaction day

₹2235.00

prior close

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Nifty Midcap 150market+0.1%+0.9% vs market

Pharmaceuticals peers, median of 167sector-0.4%+1.5% vs sector

On the reaction day the stock moved 0.9 pts more than Nifty Midcap 150 and 1.5 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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UpDownMarket · Nifty Midcap 150Sector · Pharmaceuticals peers, median of 167Pending

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AI summary

Lupin has received final approval from the US FDA for its generic Pitolisant Tablets in 4.45 mg and 17.8 mg strengths. The product is approved as bioequivalent to Wakix, used in treating narcolepsy. This strengthens Lupin's US generics portfolio and its central nervous system therapy segment, which is one of its key focus areas alongside respiratory and cardiovascular.

Likely market impact

Positive for US business. New generic approval can boost US revenue and strengthen Lupin's complex generics pipeline.