BEDMINSTER, N.J. and DUBLIN, Ireland , May 24, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today a settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva) that resolves Amarin’s previously reported Vascepa® (icosapent ethyl) patent litigation as it relates to Teva’s abbreviated new drug application seeking U.S. Food and Drug Administration ( FDA ) approval of generic forms of Vascepa (icosapent ethyl) capsules. This patent litigation continues in the United States 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 F. Thero , president and chief executive officer of Amarin .
In the lawsuit, Amarin alleges that the generic forms of Vascepa adverse parties seek to market in the United States infringe upon multiple issued patents owned by 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. The agreement is subject to a required review by the U.S. Federal Trade Commission and the U.S. Department of Justice .
About Amarin
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA -approved product, is a highly-pure, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA -regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa, known in scientific literature as
