Avanir agrees settlement with Sandoz over Nuedexta
US drugmaker Avanir Pharmaceuticals (Nasdaq: AVNR) has entered into a settlement agreement with Swiss drug major Novartis’ (NOVN: VX) generics unit Sandoz over its Abbreviated New Drug Application for a generic version of Avanir’s Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules.
Nuedexta was launched in the USA for the treatment of pseudobulbar affect (pathological crying or laughing) in late January 2011, and was recently approved for this indication in Europe ( The Pharma Letter June 26).
The settlement agreement grants Sandoz the right to begin selling a generic version of Nuedexta on July 30, 2026, or earlier under certain circumstances. The parties have also agreed to file a stipulation and order of dismissal with the US District Court for the District of Delaware which will conclude this litigation with respect to Sandoz. The settlement does not end Avanir's ongoing litigation against four other ANDA filers.
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
Free
7 day trial access
- 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
- 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
Today's issue
Company Spotlight
More Features in Generics
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze