Hikma receives favourable court ruling for its generic Vascepa®
Hikma Pharmaceuticals announced that the US Court of Appeals upheld a ruling favoring its generic version of Vascepa, indicating no infringement on six Amarin patents. This decision follows FDA approval received in May 2020, setting the stage for the product's launch. Vascepa generated approximately $1.1 billion in US sales over the last year. Hikma aims to provide affordable access to this critical medication, reinforcing its commitment to improving health for patients in the US.
- Court ruling allows Hikma to launch its generic version of Vascepa.
- FDA approval for the product obtained in May 2020.
- Vascepa has significant market potential with $1.1 billion in US sales.
- None.
LONDON, Sept. 3, 2020 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that the US Court of Appeals for the Federal Circuit today upheld a ruling by the US District Court for the District of Nevada finding that Hikma's generic version of Vascepa®1 (icosapent ethyl) 1gm does not infringe any valid claim of six key Amarin-owned patents. Hikma received FDA approval for the product in May 2020 and is working towards a launch.
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
"We are very pleased with the Federal Circuit's swift decision and to be one step closer to launching a generic version of this important medicine for US patients and healthcare providers, helping us to continue putting better health, within reach, every day," said Brian Hoffmann, President of Hikma Generics. "Today's decision demonstrates Hikma's ability to successfully challenge patents on important medicines and to provide value to our customers and millions of patients across the United States."
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal EVP, Strategic Planning and Global Affairs | +44 (0)20 7399 2760/ +44 7776 477050 |
Steve Weiss David Belian US Communications and Public Affairs | +1 732 720 2830/ +1 732 788 8279 +1 732 720 2814/ +1 848 254 4875 |
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and Ba1/stable Moody's)
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
1 Vascepa® is a registered trademark of Amarin Pharmaceuticals Ireland Limited
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SOURCE Hikma Pharmaceuticals USA Inc.
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