Boceprevir

For the treatment of chronic hepatitis C (CHC), the emergence of direct-acting antiviral agents (DAA) has completely revolutionized the traditional treatment paradigm of interferon combined with ribavirin. As a first-generation NS3/4A protease inhibitor DAA, boceprevir specifically blocks the activity of the NS3/4A serine protease of hepatitis C virus, thereby inhibiting the cleavage, maturation and replication of viral polyproteins. In clinical practice, it is mainly used in combination with pegylated interferon α and ribavirin, and is indicated for adult patients with genotype 1 chronic hepatitis C with compensated liver disease. It can significantly increase the sustained virological response rate and reduce the risk of long-term complications such as cirrhosis and liver cancer.

Globally, with the iteration of DAA drugs, although the market share of first-generation protease inhibitors has declined, boceprevir still has stable clinical demand in some regions with limited medical resources and insufficient accessibility of new-generation drugs. According to public data, its global peak sales once exceeded 1.2 billion US dollars. At present, its generic drugs are mainly concentrated in India, Southeast Asia and other regions, and the overall market size remains in the range of 300 million to 400 million US dollars, with relatively obvious rigid demand. There is no publicly verifiable statistical data on the domestic market size at present.

The original developer of boceprevir is Merck, with the original brand name Victrelis. The core compound patent of boceprevir expires in 2029 in the United States, and the core patent in Europe expires in 2030. The main dosage form approved for the original product is capsules, with a specification of 200 mg. The original capsule has been included in the FDA Reference Listed Drug Catalog, and has not yet been included in the *List of Chemical Drugs* of China. There are no boceprevir preparation products approved for marketing in China, and no valid boceprevir API registration numbers under review or publicized in Status A have been found on the CDE API registration platform. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of boceprevir impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for drug development, quality research and generic drug declaration.