Teva claims Amarain ‘locked up’ Vascepa component to block generics, following Hikma complaint

Not too long after Hikma Pharmaceuticals accused Amarin of purposefully limiting the availability of the main component of its only medicine, Vascepa, in order to prevent possible generic competition, Teva Pharmaceuticals has made a similar charge. In a complaint, Teva claimed that Amarin had engaged in anticompetitive behavior to prevent generic competitors from offering Vascepa, a heart drug made from fish oil. 

Beyond its own needs, Teva claims that Amarin purposefully controlled the supply of icosapent ethyl, the API (active pharmaceutical ingredient) in Vascepa.

Amarin has not yet replied to questions about the antitrust case. Teva’s legal team made it clear that Amarin is only concerned about Vascepa, implying a “Vascepa or nothing” approach. Teva charges Amarin with using a broad, illegal strategy, including exclusive contracts with API suppliers, to obstruct generic competition and preserve its hold on Vascepa.

Amarin’s 2013 statement, which outlines the company’s intention to safeguard Vascepa’s economic potential through the protection of patents, regulatory exclusivity, trade secrets, and the use of production hurdles, is cited in the case. Teva contends that it could have introduced its generic form of Vascepa sooner and with better accessibility if Amarin’s activities hadn’t taken place.

Teva’s case is reminiscent of identical charges made by Hikma Pharmaceuticals, which accused Amarin of same API procurement practices the year before. Hikma filed an FDA application for a generic version of Vascepa in 2016, however the drug was not allowed to be sold until 2020 due to a patent litigation filed by Amarin. Hikma learned of Amarin’s exclusive supplier agreements while getting ready for launch, and it claims they were carefully and purposefully planned.

In addition to the legal complications, Amarin had to deal with the early loss of a United States patent for Vascepa, which forced the business to refocus on the European market and resulted in significant U.S. layoffs. This change highlights the legal issues’ wider ramifications, which impact the company’s labor distribution and operational strategy in addition to the pharmaceutical industry’s rivalry.