Actavis Files ANDA for Generic Dalfampridine

Actavis plc has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market dalfampridine extended-release tablets, 10 mg.  Actavis’ ANDA product is a generic version of Acorda Therapeutics’ Ampyra, which is indicated as a treatment to improve walking in patients with multiple sclerosis.

Acorda Therapeutics, Inc. filed suit against Actavis on July 7, 2014, in the US District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain US patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA until July 22, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Actavis believes it may be a “first applicant” to file an ANDA for the generic version of Ampyra and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

In a statement, Acorda Therapeutics, Inc. said 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. The drug also has Orphan Drug status, which extends into January 2017. “Acorda intends to vigorously defend its intellectual property rights,” said the company in a statement

For the 12 months ending April 30, 2014, Ampyra had total US sales of approximately $231 million, according to IMS Health data, and as reported by Actavis in its press statement.

Source: Actavis and Acorda Therapeutics

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