XML 73 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
Subsequent Events
12 Months Ended
Dec. 31, 2013
Subsequent Events

(17) Subsequent Events

On January 8, 2014, the Company granted a total of 2,082,000 RSUs and 2,605,500 stock options to employees under the 2011 Plan. The RSU’s vest annually over a three year period and the stock options vest monthly over a four year period.

On February 21, 2014, in connection with the July 26, 2012 approval of the MARINE indication, the FDA denied a grant of New Chemical Entity (NCE) marketing exclusivity to Vascepa and granted three-year marketing exclusivity. Such three-year exclusivity extends through July 25, 2015 and can be supplemented by a 30-month stay triggered after patent infringement litigation initiated by Amarin following a valid notice to Amarin of the filing of an application to the FDA seeking approval of a generic version of Vascepa. FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition.

On February 27, 2014, the Company filed a lawsuit against the FDA that challenges FDA’s denial of the Company’s request for five-year exclusivity for Vascepa based on the Company’s reading of the relevant statute and inconsistency with FDA’s past actions. The complaint requests that the court vacate FDA’s decision, declare that Vascepa is entitled to the benefits of five-year statutory exclusivity, bar the FDA from accepting any ANDA or similar application for which Vascepa is the reference-listed drug until after the statutory exclusivity period expires, and if necessary, set aside FDA’s premature acceptance of any such application.