Vidarabine

In the field of antiviral therapy, purine nucleoside analogues have always occupied an important position due to their unique mechanism of action, and vidarabine is a classic representative among them. It exerts its effects by inhibiting the activity of viral DNA polymerase and blocking the extension of viral DNA chains, and belongs to broad-spectrum anti-DNA virus drugs. Clinically, it is mainly used for the treatment of stomatitis, dermatitis, encephalitis caused by herpes simplex virus infection and cytomegalovirus infection, and can also be used for the treatment of varicella-zoster virus infection in patients with low immune function. Its applicable population covers children and adults, and it is one of the more commonly used antiviral drugs in primary anti-infection treatment.

At present, the domestic vidarabine market presents a mature and stable development trend. Affected by the policy of restricting the use of antibiotics and the iteration of antiviral drug categories, the market size of preparations has maintained in the range of 1 to 1.5 billion yuan in recent years, among which injections account for more than 90%. The competitive landscape is dominated by generic drugs. Domestic API manufacturers are concentrated in Shandong, Jiangsu and other regions. There are more than 15 preparation enterprises that have passed the consistency evaluation. After the implementation of centralized procurement, the price of preparations has dropped by more than 80%, and the stability of upstream API supply and cost control have become the sources of core competitiveness of downstream enterprises. Through public information retrieval, there are no verifiable data on global market size and growth rate for the time being.

The original research enterprise of vidarabine is Pfizer Inc. of the United States, and the original brand name is Vira-A. The earliest US patent was applied for in 1960, and the core compound patent expired in the 1970s. The main dosage forms approved for the original research include injections and eye ointments, among which the specification of the injection is 1ml:100mg, and the specification of the eye ointment is 3%. The original reference preparation of this variety is not included in the Chinese Listed Drug Catalogue, and the reference preparation included in the FDA Reference Listed Drug Directory is Pfizer's 3% eye ointment. According to the domestic CDE API registration platform, 12 enterprises have obtained A-status registration numbers for vidarabine APIs at present, and domestic preparation varieties such as vidarabine for injection and vidarabine injection have been approved for marketing for many years. (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 vidarabine API, which can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA at the same time. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which can provide stable and reliable reference standard support for the quality research and consistency evaluation work of API and preparation enterprises.