Darunavir

As a core clinical drug of HIV protease inhibitors, darunavir selectively blocks the cleavage process of Gag-Pol polyproteins in virus-infected cells and prevents the formation of mature infectious viral particles. It belongs to the second-generation antiretroviral drugs. It is often clinically used in combination with low-dose ritonavir or other antiretroviral drugs for the treatment of human immunodeficiency virus (HIV-1) infection in adults and children over 3 years old, especially suitable for patients who are resistant to other protease inhibitors. It is a key component of the current second-line and salvage treatment regimens for AIDS, which can significantly reduce the viral load of drug-resistant patients and improve long-term treatment compliance.

The global market size of anti-HIV drugs continues to expand, exceeding USD 40 billion in 2023, among which protease inhibitor drugs account for about 12%. With the advantages of low resistance barrier and high viral inhibition rate, darunavir accounts for nearly 30% of this细分 category. In terms of the domestic market, with the expansion of the free AIDS treatment catalog and the increase in the standardized treatment rate of infected people, the annual sales of darunavir preparations have exceeded RMB 1.5 billion, with a compound annual growth rate of 18% from 2020 to 2023. At present, 8 domestic enterprises have been approved for generic preparations, and the terminal price has dropped by more than 80% after centralized procurement, and the demand for localization of upstream API has been released rapidly accordingly.

The original developer of darunavir is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and the original brand name is Prezista. The core compound patents expire in 2021, 2022 and 2023 in the United States, the European Union and China respectively. The main dosage forms approved for the original drug are tablets, with specifications including 75mg, 150mg, 300mg, 600mg and 800mg, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. Up to now, 11 domestic enterprises have completed the registration of darunavir API in CDE and activated the A status, and another 12 enterprises have been approved for marketing of darunavir preparations (including compound preparations). (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of darunavir impurity reference standards, which can fully cover the R&D demands of process impurities, degradation impurities and reference substances. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference substance support for the quality research, consistency evaluation and other links of API and preparation enterprises.