The paper deals with the problems of entering the market of generic drugs in the light of protecting the interests of copyright holder-originators. It is emphasized that the main method of protection lies in the area of intellectual rights. The protection of patent rights by companies that are copyright holders of innovative medicines comes out on top. Attention is drawn to issues related to the data exclusivity regime that are especially important in the context of establishing a balance of

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... erests not only between the copyright holders of original medicines and generic manufacturing companies, but also between representatives of the medical community. The paper considers individual rules of special normative legal acts regulating relations related to the circulation of medicines in Russia and abroad. The author draws attention to the fact that there is some terminological ambiguity, which creates difficulties in the implementation of legal regulation. Possible restrictions on the rights of companies that put into circulation generic medicines should act as a certain guarantor in the implementation of the proper legal mechanisms for the protection of the results of intellectual activity in the pharmaceutical sector and contribute to the stimulation of innovation.