Stavudine

For the long-term management of HIV infection, nucleoside reverse transcriptase inhibitors (NRTIs) have always been a core component of antiretroviral therapy regimens. As a classic drug in this category, stavudine inhibits the activity of HIV reverse transcriptase to block the process of reverse transcribing viral RNA into DNA, thereby interfering with viral replication and assembly. This drug is mainly used in combination with other antiretroviral drugs to treat type I HIV infection, and is particularly suitable for adult and pediatric patients who cannot tolerate first-line NRTIs such as zidovudine. It still has irreplaceable clinical value in the AIDS prevention and control system in resource-limited regions.

According to public data, the global market size of anti-HIV APIs exceeded USD 18 billion in 2023. Among them, stavudine, as a drug recommended by the WHO for primary anti-HIV treatment regimens, maintains a compound annual growth rate of 2.1%. At present, the production capacity of stavudine is mainly concentrated in China and India, with generic drugs accounting for more than 90% of the market share. With the full expiration of early patents, the cost of APIs has dropped by more than 85% compared with the initial stage of the original drug's launch, which has greatly improved drug accessibility in low- and middle-income countries. Currently, there is no public record of winning bids for centralized procurement of stavudine in China.

The original research enterprise of stavudine is Bristol-Myers Squibb, and the original brand name is "Zerit". Its core compound patent expired globally in 2007. The main dosage form approved for the original drug is oral capsules, with specifications including 15mg, 20mg, 30mg and 40mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Collection of National Chemical Drug Catalogs of China*. As of the retrieval time point, there are a total of 6 stavudine API registration records on the CDE API Registration Platform, among which 3 are in status A. A number of domestic enterprises have obtained marketing approval for stavudine capsules and oral solution preparations. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of stavudine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API production, quality research and compliance declaration.