Valganciclovir

For cytomegalovirus (CMV) infection, a high-incidence complication in immunocompromised populations, valganciclovir, as the L-valine ester prodrug of ganciclovir, falls into the category of nucleoside antiviral drugs. It is rapidly converted to ganciclovir after absorption through the gastrointestinal tract, competitively inhibits the activity of viral DNA polymerase, and terminates the elongation of viral DNA chains. Clinically, it is mainly used for the prevention and treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS), as well as CMV infection in patients undergoing solid organ transplantation and hematopoietic stem cell transplantation, which can significantly reduce the CMV-related severe incidence and mortality of such high-risk groups.

The global market size of valganciclovir was approximately USD 1.42 billion in 2023, and it is expected to expand steadily at a compound annual growth rate of 3.1% from 2024 to 2030. Currently, the original research products still occupy the main share of the market. With the expiration of core patents one after another, the proportion of generic drugs is gradually increasing. In terms of the domestic market, the generic preparations of valganciclovir from multiple enterprises have passed the consistency evaluation, and the average price reduction of valganciclovir preparations in provincial centralized procurement has exceeded 60%, with significantly improved accessibility.

The original research enterprise of valganciclovir is Roche, and the original trade name is Valcyte. Its core compound patent in the United States expired in 2015, and the core patent in China expired in 2020. The original dosage form is oral tablet, with the main specification of 450mg, which has been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA Reference Preparation Catalogue. In terms of domestic API registration, the valganciclovir APIs of multiple enterprises have passed the registration and publicity of CDE at present. On the preparation side, in addition to the original research products, the valganciclovir tablets of more than ten domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for valganciclovir, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the quality research and declaration and registration links of API and preparation enterprises.