Oxcarbazepine – USA

Oxcarbazepine – USA

On Dec 12, 2016, US appeals court upheld the district court decision that the 7,722,898 and 7,910,131 patents are valid and infringed by Teva with respect to Oxtellar XR (oxcarbazepine) extended-release tablets.

Supernus has been involved in patent infringement litigation against Actavis (now Teva) and TWi based on their ANDAs seeking FDA approval for generic versions of Oxtellar XR (oxcarbazepine) extended-release tablets. In February 2016, a New Jersey court decided that Teva’s generic tablets would infringe two patents that expire in 2027 (U.S. Patent Nos. ‘898 and ‘131). Teva appealed the New Jersey court’s February 2016 decision. 

Oxtellar XR is approved in the form of 150, 300, and 600 mg extended-release tablets. There are total seven patents listed in the Orange Book for Oxtellar XR (all set to expire April 13, 2027). The ʼ898 patent covers certain “homogeneous matrix” formulations of oxcarbazepine for once-daily administration.The ʼ131 patent covers methods of using such formulations for the treatment of seizures.
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