Ritonavir

In the global research and development process of antiviral drugs, ritonavir, as a classic representative of HIV protease inhibitors, has long occupied a core position in the field of antiviral therapy by virtue of its unique mechanism of action. It reversibly binds to the active site of HIV protease, blocks the cleavage process of viral gag-pol polyprotein, prevents the nascent viral particles from completing mature assembly, and thus loses their infectivity. Clinically, in addition to being one of the core components of anti-HIV combination therapy, it is often used as a pharmacokinetic booster to be combined with other antiviral drugs to increase plasma concentration and reduce dosing frequency. It is also a key component of the nirmatrelvir/ritonavir combination preparation in the treatment regimen for novel coronavirus infection, which is applicable to adult patients and adolescent patients aged 12 years and above with body weight ≥ 40kg.

Driven by the continuous increase in HIV prevention and control demand and the expansion of the COVID-19 treatment drug market, the global market size of ritonavir exceeded US$ 3.5 billion in 2022, and the compound annual growth rate has remained above 12% in recent years. The competitive landscape presents obvious stratified characteristics: the original research product occupies the mainstream share of the high-end market, and the generic drug supply side is concentrated in regions with advantageous API production capacity such as India and China. After the implementation of domestic centralized procurement, the terminal price of its oral preparations has dropped by more than 70%, the accessibility for patients has been significantly improved, which has further stimulated the market demand for upstream APIs.

The original research enterprise of ritonavir is AbbVie, and the original research trade name is Norvir. The core compound patent expired in major European and American markets in 2020, and the compound patent in China expired in 2017. The main dosage form approved by the original research is oral tablet, with a specification of 100mg per tablet, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, more than 15 domestic enterprises have obtained the A status label for their ritonavir APIs through CDE registration, and a number of domestic generic drugs corresponding to the oral preparations have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for ritonavir API. Most of the products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in API R&D, quality research and declaration work.