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.

Ampyra is currently protected by five patents listed in the FDA’s Approved Drugs Product List (Orange Book), four of which extend into 2025, 2026 and 2027, respectively. Ampyra also has Orphan Drug status, which extends into January 2017. Acorda intends to vigorously defend its intellectual property rights.