By VETTAPHARMA reporter – Derek Roche: Lupin Limited has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, indicated for the chronic management of patients with urea cycle disorders (UCDs).
The product is bioequivalent to Ravicti® Oral Liquid (1.1 grams per mL) and is used in patients whose condition cannot be adequately controlled through dietary protein restriction and/or amino acid supplementation, addressing a critical need in long-term UCD management.
Urea cycle disorders are rare genetic metabolic conditions that lead to the accumulation of toxic ammonia levels, requiring continuous treatment to prevent serious neurological complications.
From a commercial perspective, the reference product recorded approximately $337 million in US sales for the year ended December 2025, indicating a significant market opportunity for Lupin’s generic entry.
The approval supports Lupin’s strategy of expanding its complex generics portfolio in the US, particularly in niche and specialty disease areas requiring high-value therapies.
For patients with urea cycle disorders, the availability of a generic alternative is expected to improve access and affordability, especially for lifelong treatment, with increased competition potentially reducing therapy costs and enhancing treatment continuity.
