Lupin gets U.S. FDA approval for Modafinil Tablets USP

Regulatory product approvalBusiness Updates View source PDF Explain this filing

LUPIN · price

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▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

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

-0.2%Reaction day

₹2107.80

prior close

₹2121.10

announcement price

After-mkt

timing

Nifty Midcap 150market-0.5%+0.3% vs market

Pharmaceuticals peers, median of 174sector+0.2%-0.4% vs sector

On the reaction day the stock moved 0.3 pts more than Nifty Midcap 150 and 0.4 pts less than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

Minutes after the announcementfrom the announcement price · no benchmark

Stock

-0.4

10m

-0.7

15m

-0.4

30m

-0.2

Sessions after the filingfrom the prior close

StockMarketvs marketSectorvs sector

Reaction day

-0.2-0.5+0.3+0.2-0.4

Next day

-0.1-0.3+0.2+0.5-0.7

-0.4-0.8+0.4+0.2-0.6

-1.4-1.1-0.3+0.4-1.8

-0.6-1.4+0.8-0.4-0.2

-2.1-3.5+1.4-1.8-0.3

-0.9-2.6+1.6-1.1+0.2

15d

-2.6-5.7+3.0+0.3-2.9

-3.8-5.7+1.9-0.7-3.1

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UpDownMarket · Nifty Midcap 150Sector · Pharmaceuticals peers, median of 174Pending

Minute windows have no benchmark: there is no intraday index history to compare against.

AI summary

Lupin received U.S. FDA approval for its generic Modafinil Tablets USP, 100 mg and 200 mg, bioequivalent to Provigil. The drug treats excessive sleepiness from narcolepsy, obstructive sleep apnea, and shift work disorder. The reference drug had estimated U.S. annual sales of about USD 70.7 million. This adds a new product to Lupin's U.S. generics portfolio.

Likely market impact

Positive for U.S. business, entry into a market worth about USD 70 million yearly, may support revenue growth.