LONDON, May 22, 2020 /PRNewswire/ -- 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
Vascepa®1.
In March 2020, the United States District Court for the
District of Nevada invalidated six
key Vascepa® 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
Vascepa® 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."
Enquiries
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Hikma
Pharmaceuticals
PLC
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Susan
Ringdal
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+44 (0)20 7399 2760/
+44 7776 477050
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EVP, Strategic
Planning and Global Affairs
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uk-investors@hikma.uk.com
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Steve
Weiss
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+1 732 720 2830/ +1
732 788 8279
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David
Belian
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+1 732 720 2814/+1
848 254 4875
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US Communications and
Public Affairs
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uscommunications@hikma.com
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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
1 Vascepa® is a registered trademark of Amarin
Pharmaceuticals Ireland Limited.
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SOURCE Hikma Pharmaceuticals USA Inc.