Supernus Pharmaceuticals, a super-specialty pharmaceutical company, has sued generic drug makers Par Pharmaceutical Companies, and Par Pharmaceutical for infringement of four patents covering its antiepileptic drug Trokendi XR. Supernus' United States Patents Nos. 8,298,576, 8,298,580, 8,663,683 and 8,877,248 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR expires no earlier than 2027.
The Complaint—filed in the US District Court for the District of New Jersey—alleges that Par infringed Supernus' Trokendi XR patents by submitting to the Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Trokendi XR prior to the expiration of Supernus' patents. Filing its Complaint within 45 days of receiving Par's Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Par's ANDA for 30 months.
Supernus president and CEO Jack Khattar confirmed that "Supernus intends to vigorously enforce its patent rights."
Supernus is represented by attorneys from Frommer Lawrence and Haug LLP and its corporate counsel, Saul Ewing LLP.