MALVERN, PA — Endo, a wholly-owned subsidiary of Mallinckrodt plc, has introduced the first and only FDA-approved generic version of Amgen’s RAVICTI® (glycerol phenylbutyrate) oral liquid in the United States, marking a significant step in broadening treatment access for patients with urea cycle disorders (UCDs).
The generic 1.1 gm/mL oral liquid, approved through the U.S. Food and Drug Administration’s Abbreviated New Drug Application process, is indicated as a nitrogen-binding agent for chronic management of patients who cannot be effectively treated through dietary protein restriction or amino acid supplementation alone.
The launch represents a major milestone for Endo as it strengthens its position in the complex generics market and supports its upcoming corporate restructuring. “This first-to-market launch of generic RAVICTI® oral liquid is a meaningful milestone for Endo and important for our Generics business as we near the planned spin-off of Par Health,” said Scott Sims, senior vice president and general manager of Endo Injectable Solutions and Generics. “It expands access for patients and providers, and reinforces our commitment to quality, reliability, and leadership in complex generics.”
Glycerol phenylbutyrate plays a critical role in the long-term management of UCDs, a group of rare inherited metabolic conditions that affect the body’s ability to remove waste nitrogen. Patients with UCDs often require strict dietary protein limits and specialized supplements such as arginine, citrulline, and protein-free calorie replacements.
Endo’s entry into this market underscores the growing importance of high-barrier generic drugs that address niche medical needs while reducing healthcare costs. With this approval, Endo becomes the first company to offer a lower-cost alternative to Amgen’s branded therapy, helping improve treatment affordability and continuity for patients managing rare and chronic conditions.
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