Navigation Links
Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Sandoz

ALISO VIEJO, Calif., Aug. 14, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it has entered into a settlement agreement with Sandoz, Inc. to resolve pending patent litigation in response to Sandoz's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.


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 United States 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 the other four ANDA filers.

In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the Department of Justice where it is subject to review.

NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.

NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.

Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.

NUEDEXTA and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you.

NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose.

The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness.

These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at

About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit

AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.

©2013 Avanir Pharmaceuticals, Inc. All Rights Reserved.

Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development, the potential benefits of its commercialized products and products under development, and statements regarding the settlement of litigation with Sandoz and the review and approval of the settlement agreement by the U.S. Department of Justice and/or the U.S. Federal Trade Commission are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with, the difficulty of predicting the timing and outcome of litigation; risks that resolution of patent infringement litigation through settlement could result in investigations and/or actions by third parties, including government agencies; the market demand for and acceptance of Avanir's products domestically and internationally, delay in qualifying our manufacturing facilities that produce our products or production or regulatory problems with either third party manufacturers or API suppliers upon whom we may rely for some of our products or our own manufacturing facilities, obtaining and maintaining regulatory approvals domestically, including but not limited to the U.S. Federal Trade Commission and the Department of Justice, and internationally, the validity and enforceability of issued and pending patents, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Avanir Investor & Media Contact
Ian Clements, PhD
+1 (949) 389-6700

SOURCE Avanir Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Avanir Pharmaceuticals Announces Diabetes Co-Promotion Agreement with Merck
2. Avanir Pharmaceuticals Reports Fiscal 2013 Third Quarter Financial and Business Results
3. Avanir Pharmaceuticals to Participate in Two Conferences in August
4. Avanir Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
5. Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA
6. Avanir Pharmaceuticals to Participate in Two Upcoming Investor Conferences
7. Avanir Pharmaceuticals Reports Fiscal 2013 Second Quarter Financial and Business Results
8. Avanir Pharmaceuticals Announces Date of Fiscal 2013 Second Quarter Financial Results and Conference Call
9. Avanir Pharmaceuticals Receives Positive CHMP Opinion for Approval of NUEDEXTA in Europe
11. AVANIR Pharmaceuticals To paticipate in two conferences in March
Post Your Comments:
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
(Date:11/26/2015)... PUNE, India , November 26, ... --> --> ... Research Report" and "Investigation Report on ... 2019 and 2021 forecasts data and ... library. . ...
(Date:11/25/2015)... 25, 2015 ... the "Global Brain Monitoring Devices Market ... --> ) has announced the ... Devices Market 2015-2019" report to their ... ( ) has announced the addition ...
Breaking Medicine Technology:
(Date:11/29/2015)... ... , ... While conventional walkers afford considerable help with mobility, their design does ... an inventor from Uniontown, Pa., has found a way to address those needs. , ... standard walker to improve the user’s quality of life. To begin with, this improved ...
(Date:11/29/2015)... San Jose, CA (PRWEB) , ... November 29, 2015 , ... ... Bay Area, is proud to announce their December, 2015, featured apartment community: Epic. In ... looking for corporate housing in the tight Bay Area rental market to efficiently find ...
(Date:11/28/2015)... ... , ... Beginning November 30th at 6:00 a.m. EST until 11:59 p.m. EST, ... of up to 20% off orders $80 or more to free gifts with purchases, there ... , As a competitive e-commerce website for skin care and cosmetic needs, customers will save ...
(Date:11/27/2015)... ... 2015 , ... According to an article published November 6th by ... University of British Columbia suggested that laws requiring bicyclists to wear helmets may not ... of the reason for the controversial conclusion is that, while helmets have certainly prevented ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... a safe and convenient way to dispense prescription medications at home, so he ... effective way to monitor and dispense prescription medications. In doing so, it could ...
Breaking Medicine News(10 mins):