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Saturday, November 29, 2014

Actavis Plans Generic Version of Acorda’s Multiple Sclerosis Drug Ampyra

Posted by: Leonor Mateus Ferreira June 30, 2014

Acorda Therapeutics recently announced receiving a notice letter from pharmaceutical company Actavis Plc indicating their plans to commercialize a generic version of Ampyra, Acorda’s multiple sclerosis treatment drug.
Acorda claims that Actavis submitted a marketing approval application with the U.S. Food and Drug Administration (FDA) asking permission to develop and commercialize a new drug, a generic version of Ampyra, which is an extended release medication to improve walking function in patients with multiple sclerosis.

The company now has 45 days to initiate a patent infringement lawsuit against Actavis, which is expected to result in a statutory stay period to delay the FDA in approving an Abbreviated New Drug Application (ANDA) until July, 2017 at the earliest. Acorda announced the intention to vigorously defend its intellectual property rights.

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