Atovaquone

Malaria and Pneumocystis jirovecii pneumonia are infectious diseases prioritized for prevention and control in global public health, and there are long-standing clinical pain points of high drug resistance and limited medication options for special populations. Atovaquone is a hydroxynaphthoquinone antiprotozoal drug, which selectively inhibits the electron transport process of the mitochondria of Plasmodium falciparum to block the synthesis of its nucleic acid and ATP, and meanwhile exerts a targeted inhibitory effect on the dihydroorotate dehydrogenase of Pneumocystis jirovecii. It is mainly used clinically for the prevention and treatment of chloroquine-resistant falciparum malaria in adults and children, and can also be used as a component of compound preparations for the prevention and treatment of Pneumocystis jirovecii pneumonia in immunodeficient people. It is one of the core drugs for the prevention and control of infections in immunocompromised hosts at present.

At present, the global market size of atovaquone is approximately USD 230 million, with a compound annual growth rate of around 5.8% in the past three years. The core drivers of growth come from the increasing demand for malaria prevention and control in tropical regions and the expansion of the base of immunodeficient people such as organ transplant recipients and people living with HIV. In terms of the competitive landscape, the original research product still accounts for more than 60% of the share in the high-end markets of Europe and the United States. Indian generic enterprises dominate the public health markets in Southeast Asia, Africa and other regions by virtue of their cost advantages. At present, only a few domestic enterprises have the large-scale production capacity of this variety, and the supply side is highly concentrated.

The original research enterprise of atovaquone is GlaxoSmithKline, with the original brand name Mepron. The compound patent in the US market expired in 2005, and the core crystal form patent expired in 2008. The originally marketed dosage form is mainly 750mg/5ml oral suspension, which has been included in the FDA Reference Listed Drug Catalog. Currently, there is no import of this original dosage form in China. Regarding domestic API registration, as of now, there are a total of 2 A-status atovaquone API registration numbers, and domestic enterprises have already obtained approval for the marketing of atovaquone and dapsone compound tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of atovaquone impurity reference standards. The vast majority of products are in stock. Spot orders paid before 16:00 can be shipped on the same day. All products meet the regulatory requirements of multiple regions such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in different scenarios such as API R&D, quality research, and consistency evaluation.