Amarin cardiovascular news
Amarin said the U.S. Patent and Trademark Office (PTO) issued a notice of allowance for Patent Application No. 13/623,450. The patent covers claims for Vascepa icosapent ethyl (formerly AMR101) to treat hypertriglyceridemia - its approved indication. The application claims cover the use of highly pure eicosapentaenoic acid (ethyl-EPA), including Vascepa, in lowering triglycerides regardless of the drug's effect on LDL cholesterol levels.
In the event Amarin does not secure patent protection for Vascepa, 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 conference call this month, the company said FDA had not yet made a decision regarding Vascepa's exclusivity. ...