Supernus Pharmaceuticals, a specialty pharma company focused on developing and commercializing products for the treatment of CNS diseases, has sued generic drug makers Actavis plc, Actavis, Inc., Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Watson Laboratories, Inc., and Anda, Inc. (collectively "Actavis") for infringement of three patents covering its antiepileptic drug Trokendi XR.
Supernus' United States Patents Nos. 8,298,576, 8,298,580, and 8,663,683 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR does not expire until 2029.
The complaint—filed in the US District Court for the District of New Jersey—alleges that Actavis 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 Actavis' Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Actavis' ANDA for 30 months.
Supernus president and chief executive officer, 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.