Amarin Reports First Notice of US Patent Allowance on ANCHOR Clinical Trial Results
Amarin Corporation plc (Nasdaq: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for Amarin's U.S. Patent Application Serial Number 12/815,569 titled "Compositions and Methods for Lowering Triglycerides Without Raising LDL-C Levels in a Subject on Concomitant Statin Therapy." This application includes claims intended to protect the proposed Vascepa^® (icosapent ethyl) indication based on Amarin's Phase 3 ANCHOR clinical trial results. Amarin is on track to file a Supplemental New Drug Application for the Vascepa ANCHOR indication with the U.S. Food and Drug Administration (FDA) by the end of February 2013, and expects an FDA action date on the application before the end of 2013.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent and the anticipated approval of Vascepa in the ANCHOR indication.
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