Akrikhin is responsible and respects the intellectual property of third parties. We do not agree with the decision of the FAS and will appeal it in court.
To date, no court decision that has entered into legal force has established a violation of AstraZeneca AB’s exclusive right to an invention when introducing the drug Fordiglif into civil circulation.
Akrikhin company believes that the compound Dapagliflozin (patent of the Russian Federation No. 226250) and the pharmaceutical composition including Dapagliflozin (patent of the Russian Federation No. 2337916) have passed into the public domain and can be freely used in accordance with Article 1364 of the Civil Code of the Russian Federation. To protect its rights, the company «AKRIKHIN» filed a corresponding claim in court.
At the same time, we note that in a number of major countries, including China, India and Canada, the patent for Dapagliflozin has ceased to be valid.
We have always believed that the timely introduction of affordable generic drugs to the market is of great public importance. Generic drugs, such as Fordiglif, have been proven to have the same properties as the original ones. This is confirmed by bioequivalence studies. At the same time, their cost is significantly lower, which significantly expands the range of patients covered by such therapy.
Only due to the reduced price of Fordiglif, the state could spend more than 2.5 billion rubles more effectively each year. The registered maximum price of Fordiglif is 1,594.85 rubles, which is 26% lower than the original drug of AstraZeneca — Forsiga.
Akrikhin invested more than 1 billion rubles in the development and localization of full-cycle production of drugs in 2022-2023 and will continue to do so. At the same time, according to the portal of the Ministry of Health of the Russian Federation, AstraZeneca has reduced the number of clinical trials by 8 times compared to 2021: 2021 — 33 RCTs, 2022 — 5 RCTs, 2023 — 4 RCTs, 2024 — 4 RCTs.
