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:10/9/2015)... , October 9, 2015 ... die sich einer Kolonoskopie im Rahmen eines ... unterziehen. Die NOCT-Studie bewertete auch die Compliance, ... --> ® ) an erwachsenen Patienten ... eines Screenings, einer beobachtenden oder einer diagnostischen ...
(Date:10/9/2015)... , October 9, 2015 ... (OTCQB: CNBX) has announced its execution of an Intellectual Property ... Liabilities Agreement with Cannabics, Inc. a Delaware Corporation, related party, ... --> --> These ... of the Company, whereby the Research and Development components ...
(Date:10/9/2015)... India , October 9, 2015 ... --> The report ... market and overall status of the ... of guidance and direction for companies ... . ...
Breaking Medicine Technology:
... PRO-DEX, INC. (Nasdaq: PDEX ) invites investors and ... fiscal 2012 first quarter financial results. (Logo:   ... be broadcast live over the internet on Wednesday, November 9, ... and may be accessed by visiting the Company,s website at ...
... VIEW, Calif., Nov. 3, 2011 VIVUS, Inc. (NASDAQ: ... were published in Obesity, the peer-reviewed journal of The ... the investigational drug Qnexa in 1,267 severely obese (BMI >/= 35 ... addition to average weight loss of 14.4% of initial body weight ...
Cached Medicine Technology:
(Date:10/10/2015)... ... ... Isabel Healthcare will participate in the Cerner Health Conference October 11-14, 2015 ... Institute of Medicine’s latest report “Improving Diagnosis in Healthcare”, Isabel Healthcare will be featuring ... and consumers to potentially reduce the chance of error. The report suggests that most ...
(Date:10/9/2015)... ... October 09, 2015 , ... The American Osteopathic Foundation ... Graduate Medical Education J. Michael Finley, DO, as the recipient of the 2015 ... his impact on graduate medical education opportunities for osteopathic residents, and his dedication ...
(Date:10/9/2015)... ... ... A new health tool that helps identify if a sore throat is ... – just in time for the cold and flu season, which the Center for ... the U.S., the real start of cold/flu season is the start of the school ...
(Date:10/9/2015)... ... October 09, 2015 , ... Dentist in Huntington Beach ... system that uses clear, plastic aligners. This alternative to braces has become wildly ... allow patients to complete treatment in privacy. Additionally, Invisalign aligners are removable, so ...
(Date:10/9/2015)... (PRWEB) , ... October 09, 2015 , ... The Asthma ... the US Centers for Disease Control and Prevention (CDC) to improve the knowledge and ... that AAFA has been awarded a project by the CDC and allows AAFA to ...
Breaking Medicine News(10 mins):
... better diagnosis and drug treatments, study says , , WEDNESDAY, ... most common form of mental retardation -- called nonsyndromic ... that may contribute to the condition, new research finds. ... occurs during development of the child and is not ...
... virus strikes healthy kids, and it affects more youngsters than ... It,s called respiratory syncytial virus (RSV), a childhood infection that,s ... and one of every 38 emergency room trips, a new ... for inpatient hospital stays for one out of every 334 ...
... is a statement by Matthew L. Myers, President, ... and President Obama today are delivering a historic ... increasing federal tobacco taxes, including a 62-cent increase ... Children,s Health Insurance Program (SCHIP). This legislation ...
... Feb. 4 , WHAT: , ... event, with members of the cast,of Broadway,s Tony Award-winning best ... February 6, 2009 , WHO: , ... compelling stories of women making,heart-healthy choices and inspiring others with ...
... seeks new ways to prevent and treat chronic diseases such ... be conducted on the benefits of certain foods in reducing ... often cited as being high in antioxidants, which have the ... within the body, reducing the risk of cancer and other ...
... Feb. 4 Erik Olson, director of chemical and food ... the following statement today in response to the introduction of ... , , "In the midst of ... Safety Modernization Act (FSMA) could not be more timely. The ...
Cached Medicine News:
2.5V Halogen source, fiber-optic delivery, 2.5X magnification....
Pocket-sized instrument with 2.5X magnification....
Pocket-sized instrument. All Keeler otoscopes have bright halogen illumination for clear and accurate visualization of aural canal. Lithium-ion batteries with quick recharge capability. Ring rheos...
Otoscope with 4X magnification lens, swivellable to both sides, with removable cover glass to insert external instruments. Sealed system allowing for pneumatic otoscopy. 2.5V halogen source....
Medicine Products: