Actavis files for generic version of Acorda’s Ampyra

US biotech firm Acorda Therapeutics (Nasdaq:ACOR) has been advised that Ireland-headquartered generics major Actavis (NYSE: ACT) has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration to market a generic version of Ampyra (dalfampridine) Extended Release Tablets, 10mg.

Acorda is reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement law suit against Actavis in order to trigger a statutory stay period under the Hatch-Waxman Act. This would restrict the FDA from approving an ANDA until July 2017 at the earliest, unless a district court issues a decision adverse to all of Acorda’s asserted Orange Book patents prior to that date.