News Actavis Plans Generic Version of Acorda’s Multiple Sclerosis Drug Ampyra Actavis Plans Generic Version of Acorda’s Multiple Sclerosis Drug Ampyra by Patricia Silva, PhD | June 30, 2014 Share this article: Share article via email Copy article link Acorda TherapeuticsĀ recently announced receiving a notice letter from pharmaceutical companyĀ Actavis PlcĀ indicating theirĀ plansĀ 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 anĀ extended release medication to improve walking function in patients with multiple sclerosis. The company now hasĀ 45 days to initiate a patent infringement lawsuit against Actavis, which is expected to result inĀ a statutory stay period to delay the FDA in approving an Abbreviated New Drug Application (ANDA)Ā until July, 2017 at the earliest.Ā Acorda announced the intention to vigorously defend itsĀ intellectual propertyĀ rights. [adrotate group=”4″] The drug, which has net sales of $72.5 million,Ā 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 toĀ proactively manage the daily challengesĀ associated with the disease. TheĀ MS self app is part of theĀ MoveOverMS.orgĀ initiative from Acorda, an extension of the company’s web-based tools, and includes a thoughts journal, Fact Cards, and documentation of individual progress. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags Acorda Therapeutics, Ampyra
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