That's today...it's not done.
05/28/15 -- Amarin Corporation plc (NASDAQ: AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin's motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration (FDA) seeking an order requiring FDA to recognize five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa®(icosapent ethyl) capsules.
Amarin believes based on the court's ruling that Vascepa is entitled to five-year marketing exclusivity starting from FDA's approval of Vascepa in July 2012, thus extending NCE exclusivity through July 25, 2017. The ruling also confirms that acceptance by FDA of abbreviated new drug applications ("ANDAs") for generic versions of Vascepa is not permitted until July 2016. The related statutory 30-month stay triggered by patent litigation following generic application resubmissions in July 2016 would then expire in January 2020. An appeal of the court's decision can be filed within 60 days.
Amarin has multiple patents covering Vascepa that expire in 2030. With this motion granted and FDA's acceptance of ANDAs not permitted, Amarin plans to move to dismiss pending Vascepa patent litigation in connection with ANDA filings previously submitted.
"Congratulations to the extended Amarin team for delivering on this value-enhancing operational goal," stated John Thero, President and Chief Executive Officer of Amarin. "NCE exclusivity helps solidify Vascepa's commercial potential and helps demonstrate Vascepa's status as a significant and novel treatment option in the management of severely high triglycerides. Amarin's goal is to protect the commercial potential of Vascepa to beyond 2030. NCE regulatory exclusivity contributes toward this goal by complementing one of the most extensive patent portfolios covering a single product in the industry and existing manufacturing barriers to entry."
