BioCentury
ARTICLE | Company News

Amarin cardiovascular news

December 17, 2012 8:00 AM UTC

Amarin said the U.S. Patent and Trademark Office (PTO) issued U.S. Patent No. 8,324,195 covering Vascepa icosapent ethyl (formerly AMR101) capsules to treat hypertriglyceridemia - its approved indication. The patent is based on Patent Application No. 13/610,247 and expires no earlier than 2030.

In the event Amarin does not secure patent protection for the product, FDA can grant Vascepa either five years of market exclusivity as a new chemical entity or three years as a new product under the provisions of the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. When the NDA was approved in July, the company said such a decision usually comes in the month following NDA approval. In a Nov. 8 SEC filing, the company said FDA had not yet made a decision regarding Vascepa's exclusivity (see BioCentury, Oct. 29). ...