Zidovudine

As the first approved anti-retroviral drug on the market, zidovudine belongs to nucleoside reverse transcriptase inhibitors. It competitively inhibits the activity of HIV reverse transcriptase and blocks the synthesis of viral DNA chains, thereby inhibiting the replication of the virus in host cells. It is a landmark drug in the field of AIDS treatment. It can be used for the combined antiviral treatment of HIV infection in adults and children, and is also the currently recognized core drug for the prevention of mother-to-child transmission of HIV, which can greatly reduce the risk of vertical transmission in newborns. Up to now, it is still the core variety in the essential medicine list for AIDS prevention and control in many low-income countries around the world.

The global zidovudine market size has remained stable for a long time. The overall market size in 2023 was approximately USD 480 million. Driven by the popularization policies for AIDS prevention and control in low- and middle-income countries, the compound annual growth rate is maintained at around 2.1%. As the core patents have long expired, the current global market is dominated by generic drug supplies. India and China are the most important API producers, together accounting for more than 85% of the global API supply share. In terms of the domestic market, zidovudine preparations have been included in the national centralized drug procurement. The winning bid price has dropped by more than 97% compared with the initial stage of the original drug's launch, and its clinical accessibility is fully guaranteed.

The original developer of zidovudine is GlaxoSmithKline, with the original brand name Retrovir. Its core compound patent expired globally in 2005. The main dosage forms approved for the original drug include tablets (300mg), capsules (100mg) and oral solutions (10mg/ml). Among them, tablets and capsules have been included in the Catalogue of Marketed Drugs in China as reference preparations, and are also included in the FDA Reference Preparations List. In terms of domestic API registration, 6 enterprises have obtained A-status registration numbers for their zidovudine APIs after passing the evaluation of the CDE, and more than 10 other enterprises have obtained approval for marketing their preparation products, covering multiple dosage forms such as tablets, capsules and oral solutions. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for zidovudine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of API enterprises in the whole process of R&D, registration and quality control.