Analysis of registration and production of vitamin K antagonists in the EAEU member states

Objective. To identify trends in the development of the pharmaceutical market for vitamin K antagonists in the member states of the Eurasian Economic Union (EAEU), focusing on the rates of drug registration and the localization of production for active pharmaceutical ingredients (APIs) and finished dosage forms.
Materials and methods. A search for drug registration certificates was conducted in the state registries of medicines of the Russian Federation, the Republic of Belarus, the Republic of Kazakhstan, the Republic of Armenia, and the Kyrgyz Republic. A database on the state registration and production of vitamin K antagonists was developed in Microsoft Excel. The methods of content analysis, critical analysis, and classification were used.
Results. According to the 2025 ATC Index, code B01AA (vitamin K antagonists) includes 10 active substance names (10 INNs). In the EAEU territories, only 3 INNs have been registered (warfarin, acenocoumarol, and phenindione). In Kazakhstan, Armenia, and the Kyrgyz Republic, only warfarin preparations are registered under the B01AA code. In Russia, the largest number of drugs were approved between 2010 and 2016 (8 trade names). Since 2017, there has been a negative registration trend, and currently only 5 trade names of drugs are available. The production of the warfarin API is not localized in Russia (manufacturing countries include India, China, the Republic of Belarus, the Czech Republic, and others). The production of finished dosage forms is localized in Russia for 50 % of the approved medicines.
Conclusions. A trend towards a narrowing range of vitamin K antagonists and negative registration dynamics in Russia have been identified, including the cancellation of the state registration of the only phenindione drug since 2023. Warfarin and acenocoumarol are available in Russia, while warfarin and phenindione are available in Belarus. In other EAEU member states, only warfarin is used among vitamin K antagonists. This negative trend can be explained by the inconvenience of warfarin use, the need for careful laboratory monitoring of therapy, and the introduction of direct oral anticoagulants to the pharmaceutical market. The production of the warfarin API is not localized in Russia. The finished dosage form production for every second warfarin drug registered in the Russian Federation is localized domestically.

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