Lupin Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid.
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Lupin Limited has received approval from the U.S. FDA for its Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. This is an Abbreviated New Drug Application (ANDA), making it a generic version of Horizon Therapeutics' Ravicti® Oral Liquid. The drug is bioequivalent to the reference listed drug and is used for chronic management of urea cycle disorders (UCDs) in patients who cannot be managed through dietary protein restriction alone. The reference product Ravicti® had sales of USD 337 million in the U.S. market for the year ended December 2025, indicating a significant addressable market for Lupin's generic version.
This FDA approval marks Lupin's entry into a niche but substantial U.S. market for a specialty orphan drug. As a generic approval, it enables Lupin to compete in the U.S. market for this urea cycle disorder treatment, potentially boosting its revenue from the U.S. generics portfolio. For investors, this represents a positive regulatory development that expands Lupin's product pipeline in the specialty medicines segment.