FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Court Rules Taiwanese Company Infringed on Supernus’ Oxtellar Patents

Aug. 30, 2017
A A

A New Jersey federal court ruled that a Taiwanese firm infringed on patents held by Maryland-based drugmaker Supernus.

The court ruled that TWi Pharmaceuticals infringed on three of Supernus’ patents in its ANDA for a generic version of Oxtellar (oxcarbazepine), used to treat central nervous system diseases such as epilepsy. The ruling, issued after a four-day bench trial, confirmed the validity of the three patents.

U.S. District Judge Renee Marie Bumb ordered the companies to jointly submit a proposed form of final judgment consistent with the order by Aug. 25.

The FDA issued an untitled letter to Supernus last November over misleading claims for Oxtellar. The agency said advertising for the drug used language that implied the extended-release formulation was intended for multiple seizures, but the approved indication is for partial seizures.

View today's stories