Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the Company has submitted applications to extend patent protection for AMPYRA™ (dalfampridine) Extended Release Tablets, 10 mg to the United States Patent and Trademark Office (USPTO).
AMPYRA was approved by the U.S. Food and Drug Administration (FDA) on January 22, 2010 and has seven years of exclusivity in multiple sclerosis (MS) based on orphan drug status, which has been confirmed by the FDA. Acorda has applied to extend two AMPYRA patents listed in the FDA Orange Book based on provisions in the Hatch Waxman Act that allow for up to five additional years of patent protection based on the development timeline of a drug. These patents currently expire on December 6, 2011 and July 30, 2013. If both are granted, the Company will need to select one patent for extension.
AMPYRA is now available by prescription in the United States.
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