Luliconazole

Superficial fungal infection, as a high-incidence disease in dermatology, has long affected patients' quality of life due to its high recurrence rate and prolonged course of disease. The iteration of antifungal drugs has always been the focus of clinical attention. Luliconazole is an imidazole broad-spectrum antifungal drug, which exerts its effect by inhibiting the synthesis of ergosterol in fungal cell membranes. It has strong antibacterial activity against dermatophytes, yeasts, molds, etc., and its antibacterial activity is superior to that of similar drugs such as ketoconazole and miconazole. Its indications cover tinea manuum, tinea pedis, tinea corporis, tinea cruris, tinea versicolor and cutaneous candidiasis, and it is applicable to people of all ages with superficial fungal infection who have no history of drug allergy. Due to the advantages of good skin retention and only once-daily administration, clinical compliance is significantly improved.

At present, the global market size of topical antifungal drugs is growing steadily, among which imidazole drugs account for about 32%. As a new generation of topical antifungal drugs, luliconazole has achieved a global market compound annual growth rate of 8.7% in the past three years. In terms of the domestic market, with the advancement of the centralized procurement policy, the terminal price of luliconazole topical preparations has dropped by more than 60%, and patient accessibility has been greatly improved. In 2023, the domestic market size exceeded 1.2 billion yuan, among which generic drugs accounted for more than 75% of the market. At present, the domestic supply of API is dominated by local enterprises, and 11 enterprises have obtained production approvals for luliconazole API, with a relatively scattered competitive landscape.

The original developer of luliconazole is Nihon Nohyaku Co., Ltd., with the original brand name "Lulicon". The core compound patent of luliconazole expires in 2024 in Japan, while the Chinese compound patent expired in 2020. The main dosage form approved for the original product is cream, with a specification of 1% (10g:0.1g). This original preparation has been included in the Catalogue of Marketed Chemical Drugs in China, and is the reference preparation for domestic generic drug development. As of now, there are a total of 23 luliconazole API registration entries on the CDE API Registration Platform of China, among which 18 are in status "A" (approved for use in marketed preparations). 17 domestic enterprises have obtained marketing approvals for luliconazole preparations such as creams and sprays. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for luliconazole API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises in quality research, registration and declaration, and impurity control during the production process.