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Generics manufacturers focus on MS drug Ampyra Posted 22/08/2014

Following news that Acorda Therapeutics (Acorda) was preparing to defend its intellectual property rights against a competitor’s application to the US Food and Drug Administration (FDA) to manufacture a generic version of its multiple sclerosis drug Ampyra (dalfampridine), Acorda is now facing at least six additional generics challenges.

According to a release from Acorda on 26 June 2014, the company intends to ‘vigorously defend its intellectual property rights’ against Actavis who filed the first abbreviated new drug application (ANDA). Ampyra is protected by five patents listed in 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 has reportedly filed separate infringement lawsuits in the US District Court for the District of Delaware against the following ANDA applicants: Actavis on 24 June, Aurobindo Pharma on 26 June, Roxane Laboratories on 1 July, Alkem Laboratories on 2 July, Accord Healthcare on 7 July and Mylan on 9 July 2014.

On 17 July 2014, Acorda joined forces with Alkermes Pharma Ireland (Alkermes), filing against Teva Pharmaceuticals USA, for patent infringement of the five Ampyra patents. Alkermes is the assignee of one of the Ampyra patents, with Acorda being the exclusive licensee to exploit the patent in the US.

Actavis believes it may be the ‘first applicant’ to file an ANDA for the generic version of Ampyra and may, should its ANDA be approved, be entitled to 180 days of generics market exclusivity. Meanwhile, Acorda has said that once it has launched a patent infringement lawsuit, a statutory stay period would be triggered under the Hatch-Waxman Act, restricting the FDA from approving an ANDA until July 2017 at the earliest (unless a district court issued a decision adverse to all of Acorda’s asserted Orange Book patents prior to that date).

Ampyra, which received US FDA approval in January 2010, is a twice-daily pill that repairs damaged nerve signals that cause MS symptoms such as limited mobility.

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Source: Acorda, Actavis

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