Atazanavir

Long-term control of HIV infection is highly dependent on the optimization of highly active antiretroviral therapy regimens. As a core component of the regimens, protease inhibitors significantly reduce the risk of disease progression in patients by blocking the cleavage and maturation process of viral polyproteins. Atazanavir is an azapeptide HIV-1 protease inhibitor, which can bind to the active site of viral protease with high selectivity, maintain stable viral inhibition effect at low doses, and still be active against some drug-resistant strains. It is often clinically used in combination with other antiretroviral drugs to treat HIV-1 infected adults and children aged 3 months and older with body weight ≥5 kg. Due to its metabolic feature of less impact on blood lipids, it is particularly suitable for infected people with combined metabolic abnormalities who require long-term control.

The global market size of anti-AIDS drugs exceeded USD 37 billion in 2023, among which the protease inhibitor segment accounts for about 12%, with a compound annual growth rate of around 3%. In the domestic market, atazanavir is still mainly supplied by the original research manufacturer at present. With the continuous advancement of domestic policies on the accessibility of anti-AIDS drugs and the expansion of the coverage of relevant therapeutic drugs in centralized volume-based procurement, the generic substitution space for this variety is gradually releasing, and the demand of downstream preparation enterprises for compliant API is also showing a steady upward trend.

The original research manufacturer of atazanavir is Bristol-Myers Squibb, with the original brand name Reyataz. Its core compound patent in the United States expired in 2017, and the core patent in China expired in 2019. The main dosage form approved for the original research product is oral capsule, with specifications including 100mg, 150mg, 200mg and 300mg. The original research preparation has been included in the China Listed Medicines Catalogue as the reference preparation, and is also included in the FDA Reference Listed Drug Catalogue. At present, domestic generic preparations have been approved for marketing in the domestic preparation market. According to the API registration platform, atazanavir API from a number of enterprises have been approved for registration and can be used in association with preparation declaration. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for atazanavir API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The full series of products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully support the reference standard needs in all links of API R&D, registration declaration and quality control.