Lupin has received approval from the U.S. FDA for its Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. This medication is indicated for the chronic management of urea cycle disorders (UCDs) in patients who cannot be managed by dietary protein restriction alone. The reference listed drug, Ravicti®, recorded annual product sales of USD 337 million for the year ended December 2025, marking a significant market opportunity for Lupin.
Breakthrough in Urea Cycle Disorder Treatment
Lupin has successfully secured U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Glycerol Phenylbutyrate Oral Liquid. This therapeutic solution, dosed at 1.1 grams per mL, is bioequivalent to the reference listed drug, Ravicti®, which is owned by Horizon Therapeutics U.S. Holding LLC, a subsidiary of Amgen Inc.
Strategic Market Significance
The approval represents a key milestone for Lupin in its commitment to expanding its complex generics portfolio. With the reference product generating approximately USD 337 million in annual sales as of December 2025, this launch is expected to enhance Lupin’s competitive standing in the U.S. pharmaceutical market. The medication addresses a critical need for patients suffering from urea cycle disorders who require specialized long-term management beyond simple dietary changes.
Commitment to Patient Health
This addition to Lupin’s product line underscores the company’s focus on complex healthcare solutions. By providing a bioequivalent alternative to an established treatment, Lupin continues to leverage its global research and manufacturing capabilities to improve access to essential medications for patients worldwide.
Source: BSE
