Efinaconazole

Onychomycosis is a highly prevalent superficial fungal infectious disease in clinical settings. Due to the special structure of the nail plate, traditional topical drugs have poor permeability, and oral drugs carry high risks of liver and kidney damage, which have limited clinical treatment options for a long time. Efinaconazole is a triazole antifungal drug. It specifically inhibits the 14α-lanosterol demethylation process mediated by fungal cytochrome P450, thereby blocking the synthesis of ergosterol in the fungal cell membrane. Meanwhile, it has high lipophilicity and keratophilic properties, and can maintain an effective drug concentration in the nail plate for a long time. It is mainly used clinically for the topical treatment of toenail onychomycosis in adults, and can also be used in combination with oral drugs for the intervention of refractory onychomycosis, especially suitable for elderly people who cannot tolerate systemic antifungal treatment and people with abnormal liver and kidney functions.

Driven by the continuous increase in the prevalence of tinea pedis and onychomycosis, as well as the increasing demand of patients for the safety of topical medication, the market size of efinaconazole has shown a steady growth trend in recent years. Relevant data show that in 2023, the global market size related to efinaconazole exceeded 420 million US dollars, and the annual growth rate of the Chinese market remains above 18%. At present, the original research products still dominate the market, and a number of domestic pharmaceutical companies have arranged for the research and development of generic drugs. With the expiration of relevant patents, the launch of generic drugs will further promote the improvement of clinical accessibility, and the market penetration space is expected to further expand.

The original research enterprise of efinaconazole is Valeant Pharmaceuticals International (now Bausch Health) in Canada, and the original trade name is Jublia®. Its US compound patent will expire in 2027, and the core patent in China will expire in 2026. The approved dosage form of the original research product is 10% topical solution, with specifications of 4mL/bottle and 8mL/bottle. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the Chinese Catalog of Reference Preparations for Chemical Drugs. Up to now, the efinaconazole active pharmaceutical ingredients of a number of domestic enterprises have obtained the CDE registration number (A status), and the 10% efinaconazole solution of the original research product and domestic generic drugs have all been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of efinaconazole impurity reference standards, most of which are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products comply with the pharmacopoeia of the People's Republic of China, FDA and other national pharmaceutical regulatory regulations, and can provide stable and reliable reference material support for pharmaceutical enterprises in API research and development, quality research and generic drug consistency evaluation.