Acorda fights Actavis on generic of its multiple sclerosis drug Ampyra

9 July 2014

Ireland-headquartered generics major Actavis (NYSE: ACT) has confirmed filing an Abbreviated New Drug Application with the US Food and Drug Administration for dalfampridine, as announced last month.

This seeks approval for the company to market dalfampridine extended-release tablets, a generic version of US-based biotech firm Acorda Therapeutics’ (Nasdaq: ACOR) Ampyra, a treatment to improve walking in patients with multiple sclerosis.

Acorda filed suit against Actavis on July 7 in the US District Court of Delaware to prevent Actavis from commercializing the product prior to the expiration of certain US patents, and resulted in a stay of final FDA approval of Actavis’ ANDA until July 22 2017, or final resolution of the matter before the court. Ampyra had total US sales of approximately $231 million in the 12 months to 30 April 2014, according to IMS Health data.

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