A little more than a year after Hikma Pharmaceuticals accused Amarin of “deliberately and meticulously” hamstringing supplies of the main ingredient in its only marketed drug, Vascepa, to thwart potential generic competition, Teva Pharmaceuticals has levied a similar challenge.
In a lawsuit filed Thursday, Teva said Amarin has engaged in “anticompetitive conduct to prevent and delay generic competition” to Vascepa—a fish-oil-derived heart med. Teva contends Amarin deliberately “locked up the supply” of Vascepa’s active pharmaceutical ingredient (API), icosapent ethyl, “in excess of its own needs.”
Amarin did not immediately respond to Fierce Pharma’s request for comment on the antitrust lawsuit.
Teva’s lawyers didn’t mince words in this week’s filing, noting that “[f]or Amarin, it is Vascepa or bust." To defend the key drug, Amarin allegedly embarked on a “long, illegal anti-competitive strategy to prevent and delay generic competition and maintain its monopoly power and prices,” Tevas’s legal team argued.
According to Teva, Amarin inked multiple exclusive agreements with API suppliers in which the company agreed to purchase minimum ingredient amounts in exchange for exclusive access to the supplies.
The lawsuit went on to point to an Amarin announcement from 2013, in which the company publicly stated its goal was to "protect the commercial potential of Vascepa to beyond 2030 through a combination of patent protection, regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to entry.”
If not for Amarin's hoarding strategy, Teva claims it would have been able to launch its Vascepa generic much earlier than in late 2022 and with better availability.
Teva’s complaint follows similar accusations from generics giant Hikma, which last year accused Amarin of similar API purchasing arrangements.
Hikma first filed an FDA application for generic Vascepa back in 2016, though an Amarin patent suit ultimately kept the copycat med off the market until 2020.
Once Hikma was getting ready for its launch, it learned that Amarin had “carefully and purposefully” inked a web of exclusive supplier contracts, Hikma said in its suit.
Aside from the legal imbroglio, Amarin faced an early U.S. patent loss on the drug, forcing the company to prioritize the European market and leading to mass U.S. layoffs.