9 July 2014Americas

Acorda challenges Actavis’s Ampyra generic

US-based Acorda Therapeutics has sued Actavis for infringing four patents covering its multiple sclerosis (MS) drug Ampyra (dalfampridine).

Acorda filed the case after Actavis sent an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to sell a generic version of Ampyra before its patents expire.

According to the complaint, filed on July 7 (Monday) at the US District Court for the District of Delaware, Actavis seeks to make and sell a 10 mg dalfampridine extended release tablet to improve walking in MS patients.

Acorda asks that the court find Actavis’s ANDA filing an act of infringement, and for a permanent injunction keeping Actavis from making or selling generic Amprya tablets before expiration of the patents.

Ampyra is protected by five patents; the four at issue are due to expire in 2025, 2026 and 2027. The medicine has been granted orphan status, which protects the product from generic competition until 2017.

In a statement following its notification of the ANDA filing, Acorda said that it intends to “vigorously defend” its IP rights.

Amprya is Acorda’s flagship product. It generated sales of $72.5 million in the first quarter of 2014.

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