Amprenavir

In response to the long-term management needs of HIV infection, protease inhibitors have always been the core component of highly active antiretroviral therapy regimens. Amprenavir, as a first-generation non-peptide HIV protease inhibitor, can competitively bind to the active site of viral proteases, block the cleavage process of Gag and Gag-Pol polyproteins, and prevent the assembly of immature non-infectious viral particles into infectious mature viruses. It is mainly used clinically in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children over 4 years old, especially suitable for patient groups with decreased sensitivity to other protease inhibitors, providing an optional treatment path for people with drug-resistant HIV infection.

The global first-generation protease inhibitor market has entered a mature and stable period. Affected by the promotion of new compound preparations and long-acting anti-AIDS drugs, the overall market size is approximately US$1.2 billion, with a compound annual growth rate maintained at around -2.3%. At present, the original research product of amprenavir has gradually withdrawn from the mainstream market, and the supply of generic drugs is mainly concentrated in low- and middle-income countries such as India and South Africa. Due to limited domestic clinical demand, it has not yet been included in the national centralized volume procurement scope. Currently, the accessibility in the domestic market is relatively low, and there is no publicly verifiable specific market sales data.

The original research enterprise of amprenavir is GlaxoSmithKline, with the original research trade name Agenerase. Its compound patent for the US market expired in 2010, and the core European patent expired in 2011. The approved dosage forms of the original research include 50mg and 150mg oral capsules and 15mg/ml oral solution, which have been included in the FDA Orange Book Reference Listed Drug Catalog. Up to now, there is no registered amprenavir API DMF registration number in the database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, nor has any amprenavir preparation declared by domestic enterprises or imported enterprises been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of amprenavir impurity reference standards, covering all relevant impurities involved in the synthesis process and degradation pathways. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the quality compliance requirements under multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API R&D, quality research and consistency evaluation.