Generic RAVICTI Options Moving Forward
October 20, 2025—Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today the launch of a generic version of Amgen's RAVICTI® (glycerol phenylbutyrate), 1.1 gm/mL oral liquid, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Their announcement did not include any details on when the generic drug will become available or any details on pricing.
In addition, as previously announced at the 2025 NUCDF Family Conference, a separate, fully funded philanthropic initiative to develop an affordable and accessible generic option is also underway.
NUCDF recognizes that there is uncertainty regarding generic glycerol phenylbutyrate. We have heard the concerns expressed by the patient community regarding the timing and availability of generic options and what impact that may have on patient access to these lifesaving medications.
In alignment with our mission, NUCDF remains dedicated to supporting all initiatives that enhance access. Our goal is to ensure that patients will have consistent and affordable access to this essential medication. We will continue to seek and share the latest information on this topic as it becomes available.
Read the announcement from Endo here: https://www.prnewswire.com/news-releases/endo-launches-first-and-only-generic-version-of-ravicti-glycerol-phenylbutyrate-oral-liquid-in-the-united-states-302588244.html
