Supernus sues Par over proposed Trokendi generic

US-based Supernus Pharmaceuticals has sued generic drug maker Par Pharmaceutical for allegedly infringing four patents covering its extended release anti-epileptic drug Trokendi XR (topiramate), the company announced on Friday (January 16).

The four patents, US numbers s 8,298,576; 8,298,580; 8,663,683; and 8,877,248, cover once-a-day formulations of the drug’s active ingredient and methods for treating seizures.

Supernus received the latter of these patents in November last year. It is due to lose patent protection for the drug in 2027.

In the complaint, filed at the US District Court for the District of New Jersey, Maryland-based Supernus argued that Par infringed the four patents by sending an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) that sought approval to market a generic version of Trokendi XR before its patents expire.

By filing the complaint within 45 days of receiving a notice of Par’s application, Supernus has secured an automatic stay that prevents the FDA from approving the ANDA for 30 months.

Jack Khattar, president and chief executive of Supernus, said the company intends to “vigorously enforce” its patent rights.

A spokesperson for Par told LSIPR that the company does not comment on pending litigation.