Ravuconazole

The mortality rate of invasive fungal diseases has remained high for a long time. The problems of drug resistance and hepatotoxicity of existing antifungal drugs have always been unmet clinical needs, and the advent of ravuconazole provides a new solution to this dilemma. As a second-generation triazole antifungal drug, it highly selectively inhibits 14α-sterol demethylation mediated by fungal cytochrome P450 to block the synthesis of ergosterol in fungal cell membranes. It exhibits strong antibacterial activity against a variety of pathogenic fungi such as Candida, Aspergillus, Cryptococcus neoformans, etc., and is also effective against some strains resistant to fluconazole and itraconazole. It is mainly used to treat invasive fungal infections in immunodeficient patients, including those with severe infections such as candidemia, invasive aspergillosis, and cryptococcal meningitis.

At present, the global market size of antifungal drugs has exceeded 15 billion US dollars, with triazole drugs accounting for nearly 45%, which is the core category of clinical antifungal therapy. As a new generation of triazole drugs, ravuconazole has maintained a market growth rate of more than 12% in recent years due to its better antibacterial spectrum and safety, which is significantly higher than the average growth rate of traditional triazole drugs. The current market is still dominated by original research products. More than ten pharmaceutical companies around the world have laid out generic drug research and development, among which Indian pharmaceutical companies have taken the lead in submitting abbreviated new drug applications. China is currently in the early stage of generic drug research and development, no relevant products have been included in the centralized procurement list, and the market competition pattern has not yet been solidified.

The original research enterprise of ravuconazole is Eisai Co., Ltd. of Japan, and the original research trade name is Razebux. The core compound patent of ravuconazole expires in Japan in 2026, and the core patents in the United States and Europe expire in 2027. The main dosage form approved for the original research product is oral tablet, with specifications of 50mg and 100mg, and it has been included in the FDA Orange Book Reference Listed Drug Catalog. There is no approved registration number for this API in China, and no ravuconazole-related preparations have been approved for marketing by the NMPA. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the impurity research needs in the process of ravuconazole generic drug research and development, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the quality research and declaration registration work of R&D enterprises.