Announced Thu, 8 Oct, 2026 · 20:58 IST
Lupin gets US FDA approval for Phytonadione Injectable Emulsion
LUPIN · price
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Price reaction · full curve
Awaiting price reaction for this filing.
AI summary
Lupin received US FDA approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe, used to treat low blood clotting and vitamin K deficiency. The product is bioequivalent to the reference drug from International Medication Systems. Estimated US annual sales for this product stand at about USD 52.3 million based on IQVIA MAT August 2026 data. This adds a new product to Lupin's US generics portfolio.
Likely market impact
Positive for US business. Entry into a USD 52.3 million market adds to US generics revenue potential and strengthens the portfolio.