Lupin has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Glycerol Phenylbutyrate Oral Liquid, 1.1 g/mL, indicated for the treatment of Urea Cycle Disorders (UCDs).
The approved product is the generic equivalent of Ravicti® Oral Liquid developed by Horizon Therapeutics U.S. Holding LLC. It is prescribed for the chronic management of patients with UCDs who are unable to maintain normal ammonia levels through dietary management and amino acid supplementation alone.
The approval marks another important milestone for Lupin as the company continues to strengthen its specialty and complex generics portfolio in the United States. Urea Cycle Disorders are rare metabolic conditions that require long-term and carefully monitored treatment, making access to affordable therapies especially important for patients and caregivers.
According to IQVIA MAT December 2025 data, the reference product generated annual sales of approximately USD 337 million in the U.S. market. The latest approval is expected to enhance Lupin’s presence in the rare disease segment while reinforcing its commitment to expanding access to critical healthcare solutions globally.
