Actavis Plans Generic Version of Acorda’s Multiple Sclerosis Drug Ampyra
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.
The drug, which has net sales of $72.5 million, was approved in January, 2010 and is currently protected by five patents listed on the U.S. Food and Drug Administration (FDA) Approved Drugs Product List, with extended protection until between 2025 and 2027. Ampyra also has Orphan Drug status until January 2017, a designation given to medications specifically developed to treat rare medical conditions, which offer drug developers certain benefits, such as faster approval processes and more funding.
In addition to the drug treatment Ampyra, Acorda has also developed an award-winning MS self mobile app, designed to empower MS patients with the ability to proactively manage the daily challenges associated with the disease. The MS self app is part of the MoveOverMS.org initiative from Acorda, an extension of the company’s web-based tools, and includes a thoughts journal, Fact Cards, and documentation of individual progress.