Icosapent Ethyl

LONDON, June 4, 2026 /PRNewswire/ -- Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc., (Hikma) offered the following comments on today's unanimous decision by the Supreme Court of the United States effectively ending Amarin's patent infringement litigation against the company. "Hikma has long fought for patients and their access to safe, high-quality, and affordable medicines," said Sam Park, General Counsel, Hikma. "We welcome the United States Supreme Court's decision, which allows us to continue providing millions of American patients with generic medicines that improve health and save lives." "Our more than 2,300 US employees and their Hikma colleagues around the world remain hard at work developing, manufacturing and distributing essential generic medicines that have become a cornerstone of the US health care system and that serve the needs of hospitals, doctors, pharmacists and patients nationwide," said Mr. Park. The dispute between the companies involved Hikma's icosapent ethyl, a medicine made from purified fish oil for people with severe hypertriglyceridemia. Hikma obtained FDA approval and in 2020 launched a generic version of Amarin's branded icosapent, Vascepa® covering only the non-patented use of the medicine. This is known in the industry as a 'skinny label.' The law enabling skinny labelling is designed to bring cheaper medications to patients more quickly. Amarin sued Hikma, wrongly alleging that Hikma was marketing the generic icosapent ethyl for both the patented and non-patented uses. A US district court dismissed Amarin's suit, but a federal appeals court overturned that ruling and allowed Amarin's case to proceed. Hikma then appealed to the Supreme Court. "Hikma took this fight to the Supreme Court to ensure patients have ongoing access to generic medicines, especially those medicines that have appropriately carved out patented indications," continued Mr. Park. "Amarin's lawsuit sought to limit legitimate generic competition, despite long-established legal frameworks governing generic medicines in the US. We are very pleased the US Supreme Court has ended this litigation, which will have a beneficial impact on all Americans." Hikma also thanks the many organizations and individuals who supported its position before the Court. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P and BBB/stable Fitch) Enquiries SOURCE Hikma Pharmaceuticals USA Inc. 21% more press release views with Request a Demo

By a unanimous 9-0 vote, the U.S. Supreme Court has sided with Hikma Pharmaceuticals, ruling that its "skinny label" generic version of Amarin’s fish-oil drug Vascepa does not infringe patents held by the Irish company. With a resounding unanimous vote, the U.S. Supreme Court has sided with Hikma Pharmaceuticals, ruling that its generic version of Amarin’s fish oil-derived cardiovascular drug Vascepa does not infringe patents held by the Irish company. The ruling is a triumph for the generic drug industry and—in particular—for its use of “skinny” labels, which allow cheaper knockoff versions of drugs to be marketed for specific indications, provided they don’t infringe on patents protecting other uses.With its 9-0 vote, the Supreme Court overturned (PDF) a lower-court decision, which ruled that Hikma had infringed on Amarin’s patents.The ruling surrounded Amarin’s patent protection for Vascepa, which was approved by the FDA in 2012 to treat severe hypertriglyceridemia, a condition in which triglyceride (fat) levels in the blood are dangerously high and can cause heart problems. In 2019, the FDA signed onto a label expansion for Vascepa, approving the drug to treat those with less-elevated levels of triglycerides and to reduce the risk of a variety of heart conditions. This secondary expansion opened up Vascepa to millions of patients in the United States as an alternate to statins in lowering cholesterol levels.While Amarin’s patents for severe hypertriglyceridemia were invalidated in 2020, it still has protection for the less-severe form of the condition. The company reported sales of the treatment at $214 million last year.Also in 2020, Hikma gained a “skinny label” approval for its copycat version of Vascepa and that same year, Amarin sued the London-based generics specialist. Amarin claimed that the way the Hikma marketed its product, calling it “generic Vascepa” in press releases, encouraged doctors to prescribe it for all its approved indications. Amarin’s lawsuit was initially rejected by a Delaware court in 2022 but two years later a U.S. appeals court decision revived the complaint. Amarin claimed that Hikma's marketing efforts differed from those of the other seven companies that have gained approval for their Vascepa generics.  On Thursday morning, however, Justice Ketanji Brown Jackson wrote that “Amarin’s allegations, whether viewed together or separately, fail to establish that Hikma took any affirmative steps to encourage infringement.”“The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements as instructions to infringe,” Jackson added. In the ruling, Jackson echoed similar issues that were brought up by U.S. Solicitor General John Sauer and other Department of Justice (DOJ) lawyers earlier this year in a briefing that supported Hikma’s stance.“Pleading a claim of active inducement to infringe a patent requires, at minimum, factual allegations that plausibly explain how the defendant’s statements or actions—beyond the bare sale of a product that may be put to infringing use—actively encouraged and caused direct infringement by a third party,” Sauer wrote. “Amarin’s complaint includes no such allegations.”On Thursday, Patients For Affordable Drugs CEO Merith Basey applauded the decision, saying that it “protects an important pathway for bringing lower-cost generic medicines to patients.”“Had the court ruled the other way, generic manufacturers could have faced increased legal risk when following the rules established by Congress and the FDA. That would have meant fewer generic challenges, delayed competition, and higher drug prices for patients and taxpayers,” Basey added.