Mumbai: Global pharmaceutical major Lupin Limited announced the launch of an authorized generic version of Ravicti® (Glycerol Phenylbutyrate) Oral Liquid, 1.1g/mL, in the United States. This strategic move strengthens Lupin’s presence in the U.S. specialty pharmaceutical market and expands access to critical therapies for patients suffering from rare metabolic disorders.
The authorized generic, Glycerol Phenylbutyrate Oral Liquid, 1.1g/mL, is indicated for the chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. UCDs are rare genetic conditions that impair the body’s ability to eliminate ammonia from the bloodstream. If left untreated, elevated ammonia levels can lead to severe neurological complications, coma, and even death. The availability of this generic formulation is expected to provide a more affordable treatment option for patients and healthcare providers in the United States.
Ravicti®, originally developed and marketed by Horizon Therapeutics, is a well-established therapy for UCDs. Lupin’s authorized generic version has been launched under a licensing agreement, ensuring that the formulation, quality, and therapeutic efficacy remain consistent with the branded product. The launch is part of Lupin’s broader strategy to expand its complex generics portfolio and address unmet medical needs in the rare disease segment.
Commenting on the launch, a Lupin spokesperson stated, “We are proud to introduce the authorized generic version of Ravicti® in the U.S. market. This launch underscores our commitment to improving access to high-quality, life-saving medications for patients with rare and chronic conditions. It also reflects our continued focus on strengthening our specialty portfolio and delivering value to the healthcare ecosystem.”
Lupin has built a strong reputation in the U.S. generics market, with a portfolio that spans branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs). The company’s U.S. business remains a key growth driver, contributing significantly to its global revenues. With this launch, Lupin aims to further consolidate its position in the niche therapeutic area of metabolic disorders.
The U.S. Food and Drug Administration (FDA) has approved Lupin’s generic version of Glycerol Phenylbutyrate Oral Liquid, 1.1g/mL, based on its equivalence to the reference listed drug. The product will be manufactured at Lupin’s state-of-the-art facilities, which comply with stringent regulatory standards and are regularly inspected by global health authorities.
The launch also aligns with Lupin’s mission to provide affordable healthcare solutions globally. By offering a cost-effective alternative to the branded product, Lupin is expected to improve treatment adherence and outcomes for patients with UCDs, many of whom face lifelong challenges in managing their condition.
UCDs affect a small population, but the burden on patients and caregivers is significant. Symptoms can manifest in infancy or later in life and may include vomiting, lethargy, behavioral changes, and developmental delays. Effective management requires a combination of dietary restrictions, supplementation, and pharmacological interventions like Glycerol Phenylbutyrate to control ammonia levels.
Lupin’s entry into this therapeutic space is timely, given the increasing focus on rare diseases and the need for more accessible treatment options. The company continues to invest in research and development, with a pipeline that includes several complex generics and specialty products targeting high-burden diseases.
With this launch, Lupin reinforces its commitment to innovation, patient-centric care, and global health equity. The company’s efforts are expected to contribute meaningfully to the broader healthcare landscape, particularly in the area of rare metabolic disorders.
