Valaciclovir

Herpes virus infectious diseases such as herpes zoster and genital herpes are not only prone to repeated recurrence, but also bring long-term distress to patients such as neuralgia and persistent skin lesions. There has always been an urgent clinical demand for antiviral therapeutic drugs with high efficiency and low toxicity. As a representative variety of nucleoside antiviral drugs, valacyclovir is the L-valine ester prodrug of acyclovir. After oral administration, it can be rapidly absorbed by the gastrointestinal tract and converted into acyclovir, exerting antiviral activity by inhibiting the synthesis of herpes virus DNA. Its bioavailability is 3-5 times higher than that of acyclovir, which can significantly reduce the frequency of administration. At present, this drug has been widely used in the treatment and recurrence prevention of herpes simplex virus and varicella-zoster virus infections, covering immunocompetent people and some immunocompromised people.

The global valacyclovir market size has maintained steady growth for a long time. In 2023, the overall market size has exceeded 1.2 billion US dollars, of which the Chinese market accounts for about 18%. With the intensification of population aging and the increasing incidence of herpes zoster year by year, the compound growth rate of the domestic market in the past three years has maintained at about 7.2%. In terms of competitive landscape, the original research product still accounts for about 30% of the high-end hospital market, while domestic generic drugs dominate the primary medical care and retail channels by virtue of price advantages. At present, more than 30 domestic enterprises have obtained preparation approvals, and the supply of API is mainly from local manufacturers. After the implementation of centralized procurement, the product price has dropped by more than 60%, which further improves clinical accessibility.

The original research enterprise of valacyclovir is GlaxoSmithKline, with the trade name "Valtrex". Its core compound patent expired in the United States in 2009, and the Chinese compound patent also terminated in 2009. The main dosage forms approved by the original research are tablets, with specifications of 0.5g and 1g, which have been included in the FDA Reference Listed Drug Catalogue and the Chinese Catalogue of Reference Preparations for Chemical Drugs. In terms of domestic API registration, the valacyclovir APIs of 12 enterprises including Huahai Pharmaceutical and Kelun Pharmaceutical have been activated through CDE registration numbers, and more than 20 valacyclovir oral preparations have been approved for marketing in China. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for valacyclovir API, most of which 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 compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research, declaration and registration, etc.