Announced Mon, 6 Jul · 08:39 IST
Granules gets Sole First-to-File status for Sodium Oxybate generic ANDA in US
GRANULES · price
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Price reaction · full curve 14 horizons · vs prior close
+3.7%1-day move
₹832.85
prior close
₹839.50
base price
After-mkt
timing
5m10m15m30m1D2D3D4D5D7D15D1M2M3M
+0.8+1.7+2.9+2.0+3.7+3.5+6.5+6.6+7.6+8.1+1.2———
Up moveDown movePending
AI summary
Granules India has secured Sole First-to-File ANDA status with the US FDA for its generic of LUMRYZ (Sodium Oxybate Extended-Release Oral Suspension), used to treat narcolepsy. First-to-file status gives 180-day market exclusivity in the US. This is Granules second Sole FTF approval, after Amphetamine Extended-Release Tablets, reinforcing its complex generics pipeline in regulated markets.
Likely market impact
180-day US market exclusivity could deliver strong revenue and pricing power; reinforces Granules complex generics growth story.