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Monday, 01 June 2020
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Friday, 22 May 2020 01:00 pm

Hikma receives FDA approval for its generic Vascepa®

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.

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Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has announced 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      

 

Hikma Pharmaceuticals PLC      

 
   

Susan Ringdal

+44 (0)20 7399 2760/ +44 7776 477050

EVP, Strategic Planning and Global Affairs

uk-investors@hikma.uk.com 

   

Steve Weiss

+1 732 720 2830/ +1 732 788 8279

David Belian

+1 732 720 2814/+1 848 254 4875

US Communications and Public Affairs 

uscommunications@hikma.com

Tags Hikma Vascepa Generic drugs FDA United States Pharmaceutical

Neha Pandey

Aware of her elements, Neha writes the best articles across industries including electronics & semiconductors, automotive & transportation and food & beverages. Being from the finance background she has the ability to understand the dynamics of every industry and analyze the news updates to form insightful articles. Neha is an energetic person interested in music, travel, and entertainment. Since past 5 years, she written extensively on sectors like technology, finance and healthcare.


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