Akrikhin is launching a generic with the INN-rivaroxaban with full-cycle localization on the Russian market. The drug will help patients in the treatment of atrial fibrillation, acute myocardial infarction, deep vein thrombosis (DVT), pulmonary embolism (PE) and the prevention of venous thromboembolism (VTE) to receive therapy 20% more affordable than the original, according to the state register of maximum selling prices².

In Russia, more than 2.5 million people suffer from atrial fibrillation, and this number may increase to 3 million by 2036³. The number of cases of acute myocardial infarction reaches about 500,000 annually⁴. These diseases require long-term drug treatment⁵. A break in atrial fibrillation therapy carries a risk of stroke for patients, and a break in myocardial infarction treatment can increase mortality⁶. Until now, treatment of these diseases cost patients an average of 3,160 rubles per month⁷. Only 1/3 of the need for therapy is covered by the benefit⁸.

Two studies have demonstrated the bioequivalence of INN-rivaroxaban produced by Akrikhin to the original rivaroxaban drug^9,10. The safety profile of the drug is similar to the originator^8,9. It will be available in all possible dosages, including a 30-tablet package, which will allow doctors to calculate a full course of treatment for a month.

The production of our drug is concentrated entirely in Russia — this will allow us to spend state funds more efficiently and provide more patients with subsidized drugs. The estimated retail price of the drug in retail will be up to 1,000 rubles per package of 30 tablets, which is more than 3 times lower than the current price¹. This means that patients who do not belong to the subsidized categories of citizens will not abandon treatment due to the high cost of the drug. Until now, every fourth person did this¹¹,
— noted Denis Chetverikov, the President of the company «AKRIKHIN».

List of sources:

1. Taking into account the forecast retail price according to the actual maximum selling price of the manufacturer and the company’s price list in comparison with the retail price of the original drug INN-rivaroxaban IQVIA, MAT November 2024
2. Data from the state register of maximum selling prices, comparison of prices of INN-rivaroxaban from JSC AKRIKHIN and Bayer Pharma AG, https://grls.rosminzdrav.ru/PriceLims.aspx, Date of access: November 25, 2024.
3. HSE experts calculated how many years of life Russians lose due to heart rhythm disturbances (kommersant.ru), https://www.kommersant.ru/doc/6251386?from=doc_vrez Date of access: 09/17/2024
4. Barbarash O.L., Kashtalap V.V. Acute coronary syndrome without St-segment elevation. Results of 2021-2022. Fundamental and Clinical Medicine. 2023; 8 (1): 132-142. https://doi.org/10.23946/2500-0764-2023-8-1-132-142;
5. «Zinakoren therapy should be considered as a long-term treatment, provided that the benefit of preventing stroke and systemic thromboembolism outweighs the risk of bleeding.» GCMP of Zinakoren LP-No. (005657) — (RG-RU) dated 10.06.2024. SmPC and LV Register of the EAEU (https://lk.regmed.ru/) accessed 27.11.2024).
6. In the absence of treatment for atrial fibrillation, the risk of death increases by 1.5-2 times, the risk of stroke by 5 times (Ardashev A.V., Belenkov Yu.N., Matyukevich M.Ch., Snezhitsky V.A. Atrial fibrillation and mortality: prognostic factors and therapeutic strategies. Cardiology. 2021; 61 (2): 91-98. https://doi.org/10.18087/cardio.2021.2.n1348)
7. IQVIA, MAT, September 2024, commercial, Average cost of 30 days of treatment with Xarelto from Bayer Pharma AG.
8. Preferential provision of therapy to patients with atrial fibrillation and myocardial infarction, IQVIA, MAT, September 2024
9. Report on the results of the clinical study «An open, randomized, crossover, two-stage study of comparative pharmacokinetics and bioequivalence of the drugs Rivaroxaban, film-coated tablets, 20 mg (POLFARMA S.A., Poland), and Xarelto^®, film-coated tablets, 20 mg (Bayer Pharma AG, Germany), with the participation of healthy male volunteers, with a single dose after a meal», version 1.0 dated 01.04.2019. Internal data of the company AKRIKHIN
10. Report on the results of the clinical study ""Open, randomized, crossover, two-stage study of comparative pharmacokinetics and bioequivalence of the drugs Rivaroxaban, film-coated tablets, 10 mg (POLFARMA S.A., Poland), and Xarelto^®, film-coated tablets, 10 mg (Bayer Pharma AG, Germany), with the participation of healthy male volunteers, with a single dose on an empty stomach, version 1.0 dated 27.02.2019. Internal data of the company AKRIKHIN
11. Martsevich, S. Yu., Navasardyan, A. R., Kutishenko, N. P., & Zakharova, A. V. Evaluation of adherence to new oral anticoagulants in patients with atrial fibrillation according to the profile registry. Rational Pharmacotherapy in Cardiology, 10 (6), 625-630. URL: https://cyberleninka.ru/article/n/otsenka-priverzhennosti-k-priemu-novyh-peroralnyh-antikoagulyantov-u-patsientov-s-fibrillyatsiey-predserdiy-po-dannym-registra-profil (date of access: 18.11.2024).