Amarin Corp said the U.S. health regulator is yet to decide on granting exclusive marketing rights to its heart drug Vascepa, sending its shares down 3 percent In extended trading.
Based on its talks with the U.S. Food and Drug Administration, Amarin does not expect the FDA's Orange Book Supplement to include an entry with respect to the regulatory exclusivity status of Vascepa. the company said.
The FDA publishes an Orange Book, which includes details of recently approved products, patent and exclusivity information.
Vascepa, which would compete with GlaxoSmithKline Plc's Lovaza, serves as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Shares of the Ireland-based company were down at $14 in extended trading. They closed at $14.41 on the Nasdaq on Monday.
(Reporting By Pallavi Ail in Bangalore; Editing by Joyjeet Das)