Announced Mon, 6 Jul · 08:35 IST
Granules India secures sole first-to-file ANDA status for Sodium Oxybate
Compliance View source PDF
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———
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AI summary
Granules India has secured Sole First-to-File status for its ANDA for Sodium Oxybate Extended-Release Oral Suspension, the generic equivalent of LUMRYZ used to treat narcolepsy. This is the company's second Sole FTF ANDA, after Amphetamine Extended-Release Tablets. The Sole FTF designation typically grants 180-day generic exclusivity in the US upon approval. LUMRYZ is marketed by Alkermes.
Likely market impact
Positive signal for US complex generics pipeline; potential 180-day exclusivity supports revenue growth and strengthens differentiated portfolio.