Amarin Corporation plc announced a settlement agreement with Teva Pharmaceuticals USA, Inc. that resolves Amarin’s Vascepa (icosapent ethyl) patent litigation as it relates to Teva’s abbreviated new drug application seeking FDA approval of generic forms of Vascepa (icosapent ethyl) capsules.
This patent litigation continues in the US District Court for the District of Nevada with parties West-Ward Pharmaceuticals Corp. and Dr. Reddy’s Laboratories, Inc. and their affiliated entities.
“We are delighted to announce this settlement with Teva as it reinforces our confidence in Amarin’s patent portfolio and allows us to avoid the incremental litigation expense and distraction associated with Teva’s participation,” said John Thero, chief executive officer of Amarin.
As part of the settlement agreement, Teva may first begin selling its generic version of Vascepa in the United States on August 9, 2029, or earlier under certain customary circumstances.
Amarin said the agreement is subject to a required review by the US Federal Trade Commission and the US Department of Justice.