Hikma's favourable ruling in generic Vascepa®
London, March 31, 2020 - Hikma Pharmaceuticals PLC (Hikma, Group), the multinational generic pharmaceutical company, today confirms that the United States District Court for the District of Nevada has ruled that Hikma's generic version of Amarin Corporation's Vascepa® (icosapent ethyl) 1 gm capsules does not infringe six United States Patents, as asserted by Amarin, because the asserted claims of these patents were held to be invalid.
Hikma is working closely with the U.S. Food and Drug Administration (FDA) to gain approval for its Abbreviated New Drug Application (ANDA) for its generic version of Vascepa®. The company is evaluating its options for launching the product following FDA approval, including an at-risk launch in the event the District Court's decision is appealed.
"We are very pleased with the District Court's decision, which demonstrates our continued ability to successfully litigate to bring greater value to our customers and patients in the US," said Brian Hoffmann, President of Generics, Hikma. "We look forward to providing patients and health care providers in the US with a generic version of this important medicine."
Vascepa ® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
According to IQVIA, US sales of Vascepa ® were approximately $919 million in the 12 months ending February 2020.
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Susan Ringdal EVP, Strategic Planning and Global Affairs |
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About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable Moody's and BB+/positive S&P)
Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 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 the United States (US), 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 8,600 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: www.hikma.com
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