Supernus Sues Apotex for Infringement of Oxtellar XR Patents

ROCKVILLE, Md., June 26, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that earlier today it sued generic drug maker Apotex Inc. and Apotex Corp. (collectively, Apotex) 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.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, Oxtellar XR (extended-release oxcarbazepine) for the treatment of epilepsy, Apokyn (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson’s disease (PD), Myobloc (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults, and Xadago (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, apomorphine infusion pump for hypomobility in PD, SPN-820 (NV-5138) for treatment-resistant depression, and SPN-817 for the treatment of epilepsy.