Foscarnet Sodium

As a classic category of broad-spectrum antiviral drugs, foscarnet sodium belongs to non-nucleoside reverse transcriptase inhibitors. It can directly act on the pyrophosphate binding site of viral polymerase without intracellular phosphorylation activation, and inhibit the synthesis of viral DNA and RNA by blocking the binding of nucleotides to enzymes. It is active against a variety of DNA viruses such as cytomegalovirus, herpes simplex virus, and Epstein-Barr virus. Clinically, it is mainly used for the treatment of cytomegalovirus retinitis and acyclovir-resistant herpes simplex virus infections in patients with compromised immune function (such as patients with AIDS, organ transplantation, and hematological malignancies). It can also be used as an alternative medication for drug-resistant herpes virus infections, providing an important treatment option for patients who do not respond well to other antiviral drugs.

Currently, the global market size of foscarnet sodium is stable at around USD 320 million, with an annual compound growth rate of approximately 4.1%. The growth momentum mainly comes from the expansion of the immunodeficient population and the increase in the incidence of drug-resistant viral infections. The domestic market size is approximately RMB 380 million, with generic drugs accounting for more than 90% of the market share. Due to its early launch time, this drug has been included in the third batch of national centralized procurement. The average price reduction of selected products exceeds 70%, and clinical accessibility has been greatly improved. At present, domestic API manufacturers are mainly local enterprises, with a total production capacity of more than 200 tons per year, which can fully meet the domestic preparation production and export demand.

The original developer of foscarnet sodium is AstraZeneca from Sweden, with the original brand name Foscavir. Its core compound patent expired globally in the 1990s. The main dosage form approved for the original drug is injection, with specifications of 250ml:3g and 500ml:6g. It has been included in the FDA Orange Book Reference Listed Drug Catalog, and there is no imported original preparation marketed in China yet. In terms of domestic API registration, 6 enterprises' foscarnet sodium APIs have passed the CDE registration and public notification, with all statuses being "A" (can be used in marketed drugs). The domestically approved preparation dosage forms cover three categories: injection, cream, and eye drops, with a total number of approvals exceeding 30. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for foscarnet sodium, with most products in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the R&D and production quality control needs of pharmaceutical enterprises in different stages such as API quality research, preparation stability investigation, and generic drug consistency evaluation, providing reliable support for the quality controllability of the whole product life cycle.