AstraZeneca Wields Amarin Win In FDA Exclusivity Fight
Law360, New York (November 4, 2015, 5:03 PM EST) -- AstraZeneca is wielding a recent court victory by Amarin Pharma in hopes of securing longer exclusivity for triglyceride-reducing drug Epanova, a sign that the ruling carries significant implications for new products with older components.
The U.K. drugmaker's action came Monday in a supplement to a citizen petition it lodged last year with the U.S. Food and Drug Administration. The supplement focused on a May court ruling that vacated the FDA's denial of five-year exclusivity for Amarin Pharmaceuticals Ireland Ltd.'s omega-3 drug Vascepa.
According to AstraZeneca LP, the ruling "firmly supports" its request that the FDA grant five-year exclusivity to Epanova. The...
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