Lopinavir

Targeting the key protease target in the replication cycle of HIV virus, the antiviral field has long been seeking treatment regimens with both high selectivity and low drug resistance risk, and lopinavir is a representative drug in this direction. As a protease inhibitor class of antiretroviral drugs, it reversibly blocks the cleavage process of Gag-Pol polyproteins by HIV protease, preventing the assembly of viruses into mature infectious particles. In clinical practice, it is mainly used in combination with ritonavir to form a compound preparation for the treatment of HIV-1 infection in adults and children over 2 years old, and can also be used as an optional regimen for post-exposure prophylaxis. It is one of the core drugs in the free antiretroviral treatment catalog for AIDS, providing important support for improving the success rate of immune reconstruction and reducing the mortality of patients.

The global market size of antiretroviral drugs continues to expand steadily, among which protease inhibitor drugs account for about 12%. The lopinavir and ritonavir compound preparation, with its high drug resistance barrier and clear clinical benefits, still occupies an important share in the first-line treatment regimens in low- and middle-income countries. In terms of the domestic market, this compound preparation has been successively included in the National Medical Insurance Catalog and the Essential Drug Catalog. At present, more than 10 domestic enterprises have been approved to produce generic drugs. After centralized procurement, the price per box has dropped to less than 100 yuan, and the accessibility has been greatly improved. Public data shows that the domestic anti-HIV drug market has maintained an annual compound growth rate of about 15% in recent years. As a clinically essential variety, the demand for lopinavir API also maintains steady growth.

The original research enterprise of lopinavir is AbbVie, and the trade name of the original research compound preparation is Kaletra. Its core compound patent expired in the United States in 2016, and the core patent in China also expired in 2017. The main dosage form of the original research product on the market is tablet, with the specification of lopinavir 200mg/ritonavir 50mg. There is also an oral solution dosage form suitable for children, which has been included in the Chemical Reference Preparations Catalog issued by the NMPA and the FDA Reference Preparations Catalog. At present, the lopinavir APIs of nearly 20 domestic enterprises have completed registration with the CDE and obtained the A status label, and the lopinavir and ritonavir compound preparations of more than 15 enterprises 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 lopinavir impurity reference standards. Most products are regularly in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of all links such as API R&D, quality research, and registration declaration.