Supernus files lawsuit over antiepileptic drug
US pharmaceutical company Supernus Pharmaceuticals has sued Zydus Pharmaceuticals and Cadila Healthcare accusing them of infringing patents covering its antiepileptic drug, Trokendi XR (topiramate).
In the lawsuit, filed at the US District Court for the District of New Jersey, Supernus claimed that an Abbreviated New Drug Application (ANDA) filed by Zydus and its subsidiary Cadila would infringe three of its patents.
The Zydus application sought approval from the US Food and Drug Administration (FDA) to market a generic version of the drug.
But, Supernus said the FDA, which assesses ANDA applications, should not grant the application prior to the expiration of its patents in 2029.
The patents, US numbers 8,298,576, 8,298,580, and 8,663,683 cover “once-a-day topiramate formulations and methods of treating seizures”.
In a statement, Jack Khatter, president of Supernus said the company "intends to vigorously enforce its patent rights."
Supernus has two marketed products, Trokendi XR and Oxtellar XR (oxcarbazepine extended-release tablets.
According to the Nasdaq Stock Market website, Supernus depends heavily on Trokendi XR.
In the first nine months of 2014, the drug generated revenues of $42 million, comprising approximately 46% of the company’s total revenues, according to Nasdaq.
