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Supernus Sues TWi for Infringement of Oxtellar XR(R) Patents

27-Jan-2015 | Source : Supernus Pharmaceuticals | Visits : 6447
ROCKVILLE, Md. - Supernus Pharmaceuticals Inc.  announced in a press release that it sued generic drug makers TWi Pharmaceuticals, Inc. and TWi International LLC (d/b/a TWi Pharmaceuticals USA) (collectively "TWi") for infringement of four patents covering its antiepileptic drug Oxtellar XR®. Supernus' United States Patents Nos. 7,722,898, 7,910,131, 8,617,600 and 8,821,930 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. Patent protection for Oxtellar XR expires in 2027.

The Complaint — filed on January 16, 2015 in the US District Court for the District of New Jersey — alleges that TWi infringed Supernus' Oxtellar XR patents by submitting to the 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' patents. Filing its Complaint within 45 days of receiving TWi's Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving TWi'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.

Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The Company markets two products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). The Company is also developing several product candidates in psychiatry to address large market opportunities in ADHD, including ADHD patients with impulsive aggression. These product candidates include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.

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