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Biopharmaceuticals Generics FDA

 News Release - May 22, 2020

Hikma receives FDA approval for its generic Vascepa(R)

LONDON, May 22, 2020 -- (Healthcare Sales & Marketing Network) -- Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to VascepaŽ1.

In March 2020, the United States District Court for the District of Nevada invalidated six key VascepaŽ patents owned by Amarin. The District Court decision is currently being appealed.

Brian Hoffmann, President of Generics said, "The approval for our generic version of VascepaŽ is an important milestone towards bringing this product to market. This approval demonstrates the strength of our regulatory capabilities and our commitment to provide patients and healthcare providers in the US with the high-quality medicines they need."

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:

1 VascepaŽ is a registered trademark of Amarin Pharmaceuticals Ireland Limited.

Source: Hikma Pharmaceuticals

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