BioCentury
ARTICLE | Company News

Amarin cardiovascular news

October 29, 2012 7:00 AM UTC

Amarin said the U.S. Patent and Trademark Office (PTO) issued U.S. Patent Nos. 8,793,727 and 8,293,728 covering Vascepa icosapent ethyl (formerly AMR101) to treat hypertriglyceridemia -- its approved indication. The company said the PTO issued Notices of Allowance last month for the patents, which each expire no later 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. The company said in an SEC filing that as of Oct. 9, FDA had not yet made a decision regarding Vascepa's exclusivity (see BioCentury, Sept. 17). ...