Shilpa Medicare files first transdermal patch ANDA with USFDA

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

SHILPAMED · price

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

+4.1%Reaction day

₹320.00

prior close

₹329.00

announcement price

After-mkt

timing

Nifty Microcap 250market · index membership as recorded later (tracked since Jun 2026)+2.6%+1.5% vs market

Pharmaceuticals peers, median of 159sector+1.8%+2.3% vs sector

On the reaction day the stock moved 1.5 pts more than Nifty Microcap 250 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.

Minutes after the announcementfrom the announcement price · no benchmark

Stock

+4.1

10m

+1.9

15m

+3.6

30m

+4.3

Sessions after the filingfrom the prior close

StockMarketvs marketSectorvs sector

Reaction day

+4.1+2.6+1.5+1.8+2.3

Next day

+5.9+3.6+2.3+2.4+3.6

+3.4+3.1+0.4+2.0+1.4

+0.9+2.6-1.6+1.3-0.4

+1.9+1.1+0.8+0.7+1.2

+2.8+0.3+2.5+0.0+2.8

+2.8+1.6+1.1+0.7+2.0

15d

+0.6-3.9+4.6-4.4+5.0

+4.9-8.1+13.0-5.3+10.2

+30.8-3.1+33.9-3.0+33.8

+43.9+9.2+34.7+4.6+39.3

UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 159Pending

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

AI summary

Shilpa Medicare has filed an ANDA with the USFDA for Rotigotine transdermal patches in strengths 1, 2, 3, 4, 6, and 8 mg per 24 hours. It is a generic version of innovator product Neupro, used for treating Parkinson's disease and Restless Legs Syndrome. This is Shilpa's first-ever transdermal patch filing in the US, made from its Bengaluru Unit VI facility which is USFDA and Europe approved. The total addressable US market for Rotigotine is estimated at USD 112 million.

Likely market impact

Opens entry into complex transdermal patch segment with a USD 112 million US market opportunity, subject to USFDA approval.