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Amarin bags favorable court ruling on Vascepa NCE market exclusivity

  • Amarin (AMRN +18.2%) jumps on a 6x surge in volume in response to its announcement that the federal district court for the District of Columbia has granted the company's motion for summary judgement in its case against the FDA seeking an order requiring the regulator to recognize five-year marketing exclusivity for Vascepa (icosapent ethyl) as a New Chemical Entity (NCE). The company believes the market exclusivity period should extend through July 25, 2017, five years after the FDA's approval in July 2012.
  • The court's ruling also confirms that the FDA cannot accept Abbreviated New Drug Applications (ANDAs) for generic versions of icosapent ethyl until July 2016. The automatic 30-month statutory stay triggered by the submission of an ANDA would push approvals out until January 2020.
  • Amarin plans to dismiss current Vascepa patent litigation related to previously submitted ANDAs.
  • The company has another lawsuit pending against the FDA seeking authorization to communicate ANCHOR clinical trial data to doctors.
  • Previously: Amarin sues FDA to allow it to communicate ANCHOR results to docs (May 7)

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