Lupin Limited has informed the Exchange regarding a press release dated July 24, 2025, titled "Lupin Receives US FDA Approvals for Liraglutide and Glucagon Injectable Products".
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Lupin has received US FDA approval for two injectable products: Liraglutide Injection Single-Patient-Use Prefilled Pens (bioequivalent to Novo Nordisk's Victoza®, used for type 2 diabetes) and Glucagon for Injection vials (bioequivalent to Eli Lilly's product, used for severe hypoglycemia). The US market opportunity for Liraglutide is estimated at USD 458 million annually, and Glucagon at USD 124 million annually (per IQVIA MAT May 2025). Both products will be manufactured at Lupin's injectable facility in Nagpur, India. These approvals strengthen Lupin's complex injectables portfolio in the US generics market.
This is a positive development for shareholders as it expands Lupin's US product portfolio with two new approvals targeting a combined addressable market of roughly USD 580 million annually. Near-term stock impact may be limited since actual revenue depends on launch timelines, pricing competition, and market share capture, but it strengthens Lupin's long-term growth pipeline in complex injectables.