Supernus sues Actavis over generic Trokendi XR

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Supernus sues Actavis over generic Trokendi XR

INICIO/Noticias Farmacéuticas | Posted 31/10/2014 0 Post your comment

US-based central nervous system specialist Supernus Pharmaceuticals (Supernus) announced on 2 Oct 2014 that it had sued generics maker Actavis for infringement of three patents covering its antiepileptic drug Trokendi XR (extended release topiramate). The three US patents (8,298,576, 8,298,580, and 8,663,683) cover once-a-day topiramate formulations and methods of treating seizures using those formulations.

The lawsuit was filed in the US District Court of New Jersey and alleges that Actavis infringed the patents on Trokendi XR by submitting an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking to market a generic version of Trokendi XR prior to the expiration of the Trokendi patents.

Supernus has filed its complaint within 45 days of receiving the Paragraph IV certification notice from Actavis and Supernus is therefore entitled to an automatic stay preventing FDA from approving the topiramate ANDA from Actavis for 30 months.

The company has asked the court to issue a permanent injunction against Actavis and its subsidiaries, preventing them from marketing a generic version of Trokendi until after the three patents have expired in 2029.

Supernus President and CEO, Mr Jack Khattar confirmed that ‘Supernus intends to vigorously enforce its patent rights.’ This is not surprising, when considering the fact that the company launched Trokendi XR in the US only in September 2013, and was probably hoping for a little longer exclusivity.

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Source: Supernus