Lupin Limited has informed the Exchange regarding a press release dated May 05, 2026, titled "Lupin Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid".
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Lupin has received U.S. FDA approval for its generic Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. The drug is bioequivalent to Ravicti® Oral Liquid, manufactured by Horizon Therapeutics, and is used for chronic management of urea cycle disorders (UCDs) in patients who cannot be managed by dietary protein restriction alone. The reference product Ravicti® had sales of USD 337 million in the U.S. for the year ended December 2025 (IQVIA data). This approval marks Lupin's entry into this specialized therapeutic area and is a significant win for the company's U.S. generics portfolio.
This FDA approval represents a positive development for Lupin, opening access to a USD 337 million market in the U.S. It strengthens Lupin's complex generics pipeline and could contribute meaningfully to revenues going forward, as the company begins marketing this product.