Supernus Sues Apotex for Infringement of Oxtellar XR® Patents

Supernus Pharmaceuticals announced it has sued generic drug maker Apotex Inc. and Apotex Corp. for infringement of nine patents covering its antiepileptic drug Oxtellar XR®. Supernus's United States Patent Nos. 7,722,898, 7,910,131, 8,617,600, 8,821,930, 9,119,791, 9,351,975, 9,370,525, 9,855,278, and 10,220,042 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. These nine patents do not expire until April 13, 2027.

The Complaint – filed in the U.S. District Court for the District of New Jersey – alleges that Apotex infringed Supernus's Oxtellar XR patents by submitting to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Oxtellar XR prior to the expiration of Supernus's patents. Filing its Complaint within 45 days of receiving Apotex’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Apotex's ANDA for 30 months.

Supernus has previously defended the Oxtellar XR intellectual property rights separately against two earlier generic filers; namely, Actavis and TWi Pharmaceuticals and related entities. In both cases, Supernus prevailed before the District Court as well as on appeal. Oxtellar XR is currently protected by nine patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) that expire on April 13, 2027.