Gilead files patent infringement suit against Lupin over Ranexa; Mylan's generic nabumetone cleared by FDA

16 July 2010

Gilead Sciences says it has filed a law suit in US District Court in New Jersey, USA, against Indian-owned Lupin for infringement of its patents for angina drug Ranexa (ranolazine extended-release tablets). The action is based on an Abbreviated New Drug Application filed by Lupin, which seeks approval to manufacture and market a generic version of Ranexa before the expiration of the drug's patents.

Ranexa is currently protected by 10 patents, which are listed in the Food and Drug Administration's Approved Drug Products List, and all 10 patents would need to be invalidated, expire or not be infringed before a generic version of Ranexa could be marketed, says Gilead, adding that it 'has full confidence in the validity of its patents and plans to vigorously defend the intellectual property rights of Ranexa.'

Another generic nabumetone product approved for US market

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