Previously, Pfizer had attempted to block the release of the generic, citing patent protection for the original drug until 2025.
A court has overturned the decision of the Federal Antimonopoly Service (FAS), which had banned the sale of the axitinib generic by AxelPharm. The court ruled that the manufacturer had not violated antitrust laws, allowing the drug to remain on the market, as confirmed by the producer. Previously, Pfizer had attempted to block the release of the generic, citing patent protection for the original drug until 2025.
The case concerns the generic version of the anti-cancer drug with the brand name Axitinib. The original drug, known by the international nonproprietary name (INN) axitinib, is produced by the American pharmaceutical company Pfizer under the brand name Inlyta. The drug is protected by a patent until June 2025.
In January 2024, Pfizer’s subsidiary, Aguron Pharmaceuticals LLC, filed lawsuits in arbitration courts across various regions and requested interim measures. The company sought to prevent regional budgetary institutions from making payments for contracts related to the supply of the axitinib generic, which is sold under the brand name Axitinib by AxelPharm.
In November of the previous year, the Federal Antimonopoly Service (FAS) fined AxelPharm 513 million rubles for violating antitrust laws related to the introduction of the axitinib generic into circulation.
The court ruled that the actions of the drug manufacturer did not violate antitrust laws, and that the drug itself meets all requirements. As a result, it will continue to be available on the market, according to a statement from AxelPharm.
"We are pleased with the fair decision of the court, which is of fundamental importance not only for our company but also for the Russian healthcare system as a whole,"
commented Alexey Zalesov, the lawyer and patent attorney representing AxelPharm LLC.
Axitinib is used for the treatment of advanced renal cell carcinoma as a second-line therapy. The drug inhibits VEGF-mediated proliferation and survival of endothelial cells. It is included in the List of Essential Medicines (LLEM).
Source: Pharmvestnik
