Russian analogue of the Xarelto drug has been released

The subsidiary of the Promomed pharmaceutical company - JSC Biochemist has released an analogue of the best-selling medicine in Russian pharmacies, Xarelto (international nonproprietary name – rivaroxaban). At the same time, the Bayer drug is protected by a patent, which expires in December 2024.

In 2023, the drug for stroke prevention "Xarelto" was purchased in Russia for almost 15 billion rubles. The drug is considered one of the best-selling in the world, and Bayer holds the main share in revenue. Thus, according to the reports of the German company, last year's sales of Xarelto amounted to €4.1 million. The Russian drug has not yet appeared in retail sales in Russia. Currently, about 20 analogues of Xarelto from Russian and foreign companies have already been registered in the state register of Medicines, but so far only the original drug has been in circulation.

Earlier, Bayer stopped attempts to enter the generic drug market; for example, amicable agreements were concluded with Mediasorb and the Berezovsky Pharmaceutical Plant in order to avoid violating the rights of the German manufacturer. In this case, the withdrawal of the generic before the expiration of the patent for the original drug also violates Bayer's rights, according to the German company. Promomed stated that they comply with the law, including the rights of third parties to intellectual property, but recalled the risks of drug shortages. In March 2022, Bayer announced the suspension of investments in the Russian market, but supplies in the healthcare sector continued.

If the drug is protected by a patent, then the introduction of its analogue into circulation is a violation of the law, says Denis Khabarov, partner and head of the intellectual property practice of Melling, Voitishkin and Partners. But it is extremely difficult to achieve responsibility for such a violation in Russia. Patent holders demand a ban on the introduction of analogues into circulation, since with their appearance original medicines lose market share, but such disputes are complex and can go on for years and all this time the sale of analogues can continue, says Khabarov. Interim measures of protection are usually not applied in such disputes.

Federal Service for Supervision of Healthcare, when issuing a permit for the introduction of a drug into circulation, does not check whether any patent is violated or not, since this is not within its authority, says patent attorney, managing partner of Zuykov and partners Sergey Zuykov.

The press service of Federal Service for Supervision of Healthcare, responding to a question about the grounds for allowing a patent-protected drug to be put into circulation, recalled the norms of the relevant Federal Law "On the Circulation of Medicines". According to federal law, such a permit is issued on the basis of registration of a medicine by the Ministry of Health. Intellectual property issues are not subject to assessment under this procedure.

Source: RBC