ARTICLE
10 September 2018

Supernus Wins Appeal Against Second Generic Challenger To Oxtellar XR®

HP
Haug Partners

Contributor

Haug Partners is a full-service law firm that provides integrated multidisciplinary legal services for technology companies. Through relationships with firms in Germany, China, Japan, and other key international markets, Haug Partners has the resources, technical expertise, legal acumen, and business judgment to consistently deliver optimal outcomes for clients.
Following an August 6, 2018 oral argument, the United States Court of Appeals for the Federal Circuit on September 6, 2018 unanimously affirmed the District of New Jersey's August 15, 2017 ruling ...
United States Food, Drugs, Healthcare, Life Sciences
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Following an August 6, 2018 oral argument, the United States Court of Appeals for the Federal Circuit on September 6, 2018 unanimously affirmed the District of New Jersey's August 15, 2017 ruling that TWi Pharmaceuticals, Inc. and TWi International LLC (dba TWi Pharmaceuticals USA) infringed three patents owned by Haug Partners' client Supernus Pharmaceuticals, Inc. by seeking permission from FDA to market a generic version of Oxtellar XR® before the expiration of Supernus's patents. The Federal Circuit's judgment also confirms that Supernus's Oxtellar XR® patents are valid over multiple invalidity grounds argued by TWi. Oxtellar XR®—Supernus's once-a-day oxcarbazepine tablets used to treat partial seizures in adults and children—is one of two products marketed by Supernus, a Rockville, Maryland-based specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system disorders. This appellate victory should enable Supernus to realize the full value of its Oxtellar XR® patents, which the FDA's Orange Book lists as expiring on April 13, 2027.

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ARTICLE
10 September 2018

Supernus Wins Appeal Against Second Generic Challenger To Oxtellar XR®

United States Food, Drugs, Healthcare, Life Sciences

Contributor

Haug Partners is a full-service law firm that provides integrated multidisciplinary legal services for technology companies. Through relationships with firms in Germany, China, Japan, and other key international markets, Haug Partners has the resources, technical expertise, legal acumen, and business judgment to consistently deliver optimal outcomes for clients.
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