By Brendan Pierson
(Reuters) – Generic drugmaker Hikma Pharmaceuticals USA Inc has sued Amarin Pharma Inc, accusing it of using illegal tactics to delay generic competition for its heart drug Vascepa.
In a complaint filed Tuesday in Trenton, New Jersey federal court, Hikma claimed that Amarin “deliberately and meticulously locked up the supply” of the key ingredient needed to make generic Vascepa in order to maintain a monopoly.
London-based Hikma eventually launched the first generic version of Vascepa in November 2020, but it said that Amarin’s tactics delayed the launch by months, and initially prevented Hikma from supplying enough of its generic to compete meaningfully with the branded version.
New Jersey-based Amarin did not immediately respond to a request for comment. The company was already facing a similar lawsuit filed in 2021 in the same court by Indian generic drugmaker Dr. Reddy’s Laboratories Ltd, which remains pending.
Vascepa, derived from fish oil, is approved by the U.S. Food and Drug Administration to lower so-called “bad” cholesterol and reduce the risk of cardiovascular disease generally. It is Amarin’s only product.
The drug brought Amarin $598 million in 2020, but sales have since fallen as generics have entered the market, forcing the company to cut its workforce last year. The company said in a 2020 statement to investors that Vascepa had been prescribed more than 8 million times since its 2013 U.S. launch.
Amarin initially sought to block competitors by suing Hikma and Dr. Reddy’s for patent infringement after they sought FDA approval to sell generic versions of the drug, but lost after a Nevada judge ruled its patents obvious. The U.S. Supreme Court in 2021 rejected Amarin’s bid to revive the patents.
Hikma said that even after losing the patent case, Amarin held on to its monopoly by entering into exclusive agreements with suppliers of the active ingredient, icosapent ethyl, that prevented the suppliers from selling to any other companies.
Hikma called the agreements an “illegal anticompetitive strategy to prevent, delay, and frustrate generic competition and maintain its monopoly power and prices for Vascepa” and said it ran afoul of the federal Sherman Act and New Jersey antitrust law.
The case is Hikma Pharmaceuticals USA Inc v. Amarin Pharma Inc, U.S. District Court for the District of New Jersey, No. 3:23-cv-01016.
For Hikma: Charles Klein of Winston & Strawn and others
For Amarin: not available
U.S. Supreme Court denies Amarin’s bid to revive Vascepa drug patents
Amarin to slash jobs as generic rivals dull U.S. prospects of heart drug
(Reporting By Brendan Pierson in New York; editing by Alexia Garamfalvi)