Lupin Limited receives U.S. Food and Drug Administration approval for glycerol phenylbutyrate oral liquid (1.1 g/mL), a generic of Ravicti for urea cycle disorders, expanding its complex generics portfolio.
Pharmacally
Lupin Limited has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for glycerol phenylbutyrate oral liquid (1.1 g/mL). This milestone allows the company to transition from its previous status as an authorized generic distributor to an independent manufacturer of this complex therapy.
Regulatory and Market Context
The approved product is bioequivalent to the reference listed drug (RLD), Ravicti, originally developed by Horizon Therapeutics. While Lupin previously launched an authorized generic version of Ravicti in October 2025, this new ANDA approval signifies a distinct regulatory achievement for the company’s internal portfolio of complex generics. The U.S. market for this therapy has become more competitive since late 2025, with several manufacturers now providing generic alternatives to the brand-name product.
Therapeutic Indication
Glycerol phenylbutyrate is indicated for the chronic management of patients aged 2 years and older with urea cycle disorders (UCDs). These rare genetic conditions impair the body’s ability to remove ammonia, and the therapy is reserved for patients whose conditions cannot be adequately controlled through dietary protein restriction and amino acid supplementation alone.
Commercial Relevance
Although historical annual sales for Ravicti reached approximately USD 337 million for the 12 months ending December 2025, the entry of additional generic competitors is expected to influence the market landscape moving forward. This approval strengthens Lupin’s position in the niche space of complex generics, ensuring a consistent supply of therapeutic options for patients requiring long-term UCD management
Reference
Lupin Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid – Lupin | Press Release
