/PRNewswire/ -- Hikma Pharmaceuticals PLC, together with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (Hikma), issued remarks regarding the unanimous Supreme Court of the United States ruling that brings an end to Amarin's patent infringement case against the company.

"Hikma has consistently advocated for patients and their ability to obtain safe, high-quality, and affordable medications," stated Sam Park, General Counsel at Hikma. "We are pleased with the Supreme Court's decision, which enables us to keep supplying millions of American patients with generic products that enhance health outcomes and preserve lives."

"Our more than 2,300 US team members and colleagues globally continue their dedicated efforts to develop, produce, and deliver vital generic medicines that form a key part of the US healthcare framework and meet the requirements of hospitals, physicians, pharmacists, and patients across the country," added Mr. Park.

The matter centered on Hikma's icosapent ethyl product, derived from purified fish oil and intended for individuals with severe hypertriglyceridemia. Hikma secured FDA clearance and introduced a generic version of Amarin's branded icosapent, Vascepa, in 2020, limited to the non-patented indication. This approach, known as a 'skinny label,' follows legal provisions meant to accelerate delivery of lower-cost treatments to patients.

Amarin initiated legal action against Hikma, claiming improper promotion of the generic for both patented and non-patented uses. A district court rejected the claims, yet an appeals court reversed the outcome and permitted the case to advance. Hikma subsequently sought review from the Supreme Court.

"Hikma pursued this matter to the highest court to protect continued patient access to generic options, particularly those with properly excluded patented uses," Mr. Park explained. "Amarin's action aimed to restrict valid generic competition, contrary to established US frameworks for generic medicines. We are gratified that the Supreme Court has resolved the dispute, delivering positive effects for all Americans."

Hikma expresses appreciation to the numerous groups and individuals that backed its stance before the Court.

About Hikma

Hikma works to make improved health attainable daily for millions worldwide. For over 45 years, the company has produced high-quality medicines and expanded their reach to those in need. Based in the UK, Hikma operates globally with presence in North America, the Middle East and North Africa, and Europe, applying specialized knowledge to convert advanced science into practical solutions that benefit lives. The firm supports customers and those they serve by offering a wide selection of branded and generic medicines through creative and effective methods. Its 9,400 colleagues collectively advance a healthier world that benefits communities everywhere. Hikma serves as a key licensing partner and, via its venture capital efforts, aids in introducing new health technologies globally. Additional details are available at www.hikma.com

Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P and BBB/stable Fitch)

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SOURCE Hikma Pharmaceuticals USA Inc.