Russia Opens Antitrust Cases Over Generic Versions of Pfizer’s Eliquis

The Federal Antimonopoly Service, or FAS, is examining whether the companies engaged in unfair competition by introducing apixaban products while the relevant patent held by Pfizer’s Russian operation remained in force, according to The Pharma Letter.

The dispute concerns Eliquis, an anticoagulant containing the active ingredient apixaban. The drug is associated globally with Pfizer and Bristol Myers Squibb and is widely used to reduce the risk of blood clots and stroke.

The Russian proceedings involve Teva’s Apixanta and Grotex’s Apiklis, which complainants allege were introduced into commercial circulation before the patent covering the original medicine had expired, according to The Pharma Letter’s reporting.

The patent at the center of the dispute is due to expire in February 2027, the publication reported. FAS will assess the companies’ conduct under Article 14.5 of Russia’s competition law, which addresses unfair competition involving intellectual-property rights.

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The antitrust action adds another front to a broader legal fight over apixaban in Russia. Teva previously filed a lawsuit involving Pfizer Innovation, Pfizer’s Russian entity, as the companies contest rights connected with bringing apixaban products to the Russian market.

Related: Pfizer Wins Dismissal From Major Generic Drug Antitrust Case Brought by US States

Teva has said that its court action is intended to protect its legitimate economic interests and its ability to place apixaban into commercial circulation in Russia, according to reporting cited by Russian pharmaceutical media.

The dispute comes as patent litigation becomes an increasingly prominent feature of Russia’s pharmaceutical market. Competition authorities have previously intervened in disputes involving generic versions of patent-protected medicines, creating an additional regulatory avenue alongside traditional patent litigation.

For Eliquis, the Russian case also arrives as the drug approaches major patent expirations internationally. Eliquis, developed and marketed through the Pfizer-Bristol Myers Squibb partnership, has been one of the world’s highest-selling medicines. Generic competition is expected to substantially reduce sales as intellectual-property protections expire across major markets.

The Russian antitrust cases will determine whether Teva and Grotex’s actions violated competition rules; the opening of proceedings itself does not constitute a finding that either company committed a violation.

Source: Reporting by The Pharma Letter, “Russian antitrust regulator initiates case against manufacturers of generics of Pfizer’s Eliquis,” supplemented with publicly reported information on the Russian FAS proceedings and Eliquis.