US drugmaker Supernus Pharmaceuticals (Nasdaq: SUPN) says that it has sued generic drug makers Taiwan-based TWi Pharmaceuticals and TWi International for infringement of four patents covering its antiepileptic drug Oxtellar XR.
Supernus' US Patents Nos 7,722,898, 7,910,131, 8,617,600 and 8,821,930 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. Patent protection for Oxtellar XR expires in 2027, according to Supernus.
The Complaint - filed on January 16, 2015 in the US District Court for the District of New Jersey - alleges that TWi infringed Supernus' Oxtellar XR patents by submitting to the Food and Drug Administration an Abbreviated New Drug Application seeking to market a generic version of Oxtellar XR prior to the expiration of Supernus' patents. Filing its Complaint within 45 days of receiving TWi's Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving TWi's ANDA for 30 months.
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.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze