Actavis submits generic dalfampridine ANDA

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Actavis submits generic dalfampridine ANDA

Generics/News | Posted 08/08/2014 0 Post your comment

Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).

Acorda’s Ampyra, which only received US FDA approval in January 2010, is used to improve walking in patients with multiple sclerosis. The drug had net revenue of US$302.6 million in 2013, and is expected to net US$328–US$335 million during 2014.

Acorda claims that Ampyra is currently protected by five patents in the US, four of which extend into 2025, 2026 and 2027, respectively. The company now has 45 days from the date of receipt of the letter to commence a patent infringement lawsuit against Actavis. Should it do so, this would restrict 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 patents prior to that date.

Acorda stated in its press release that it ‘intends to vigorously defend its intellectual property rights’.

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Source: Acorda