Acorda Therapeutics, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Actavis Laboratories FL, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Ampyra (dalfampridine) 10 mg extended release tablets.

Acorda is reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Actavis Laboratories FL, Inc. 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.

For more details, go to: http://www.marketwatch.com/story/acorda-therapeutics-announces-notification-of-anda-filing-for-ampyra-2014-06-26