Didanosine

For the long-term management of HIV infection, nucleoside reverse transcriptase inhibitors have always been one of the core components of combined antiretroviral therapy regimens. As a classic drug in this category, didanosine exerts its antiviral effect by competitively inhibiting the activity of HIV reverse transcriptase and inserting into the viral DNA chain to terminate its extension. In clinical practice, it is mainly used in combination with other antiretroviral drugs for the treatment of type I HIV infection, especially suitable for adult and pediatric patients who are intolerant to zidovudine or have failed treatment, and it is an important treatment option for low-income regions and populations with special tolerance.

The global didanosine market is currently in a mature and stable stage. Affected by the iteration of new anti-HIV drugs, the overall market size is approximately USD 120 million, with a compound annual growth rate maintained at around -2.3%. The competitive landscape is dominated by generic drugs, and the market share of the original research product is less than 15%. India and China are the main suppliers of didanosine active pharmaceutical ingredients (APIs) in the world, accounting for more than 70% of the global production capacity in total. As this drug has been included in the public health procurement catalogs of some developing countries, the demand for generic APIs with controllable costs remains stable for a long time.

The original research enterprise of didanosine is Bristol-Myers Squibb, and the original brand name is "Videx". Its core compound patent expired in major global markets in 2006. The main dosage forms approved for the original research product include tablets, powders and enteric-coated capsules, with specifications covering 25mg, 50mg, 100mg, 200mg, etc. It has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. At present, the didanosine APIs of multiple domestic enterprises have obtained A status through CDE registration, and domestic preparations such as didanosine enteric-coated capsules and dispersible tablets have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of didanosine impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the full-process needs of API R&D, quality research and registration declaration.