Supernus sues Zydus for infringement of Trokendi XR patents

25 November 2014

US drugmaker Supernus Pharmaceuticals (Nasdaq: SUPN) has sued generic drug makers Zydus Pharmaceuticals (USA) and Indian parent Cadila Healthcare for infringement of three patents covering its antiepileptic drug Trokendi (topiramate) XR.

Supernus' US Patents Nos 8,298,576, 8,298,580 and 8,663,683 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR does not expire until 2029, according to Supernus. The company’s shares gained 2.1% to $9.07 in morning trading.

The Complaint - filed in the US District Court for the District of New Jersey - alleges that Zydus infringed Supernus' Trokendi XR patents by submitting to the Food and Drug Administration an Abbreviated New Drug Application seeking to market a generic version of the drug prior to the expiration of Supernus' patents. Filing its Complaint within 45 days of receiving Zydus' Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Zydus' ANDA for 30 months. Supernus president and chief executive Jack Khattar confirmed that "Supernus intends to vigorously enforce its patent rights."

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK