Navigation Links
Mylan Announces Settlement Agreement in Litigation Relating to its Generic Xopenex®
Date:5/29/2012

PITTSBURGH, May 29, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that Mylan Specialty L.P., f/k/a Dey Pharma, L.P., has entered into a settlement agreement with Sunovion Pharmaceuticals Inc., f/k/a Sepracor Inc., that will resolve the parties' patent litigation in connection with Mylan Specialty's Abbreviated New Drug Application (ANDA) for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.31 mg/3 mL, 0.63 mg/3 mL, 1.25 mg/3 mL and 1.25 mg/0.5mL. Levalbuterol HCl is the generic version of Sunovion's Xopenex® product. 

According to the terms of the settlement, Mylan Specialty is licensed to continue sales of its concentrate product (Levalbuterol HCl 1.25 mg/0.5mL) and will have a royalty-bearing license to sell its non-concentrate product (Levalbuterol HCl 0.31mg/3mL, 0.63mg/3mL, and 1.25mg/3mL) upon receiving final approval from the U.S. Food and Drug Administration. The settlement also releases Mylan from payment of the $18 million jury damage award to Sunovion.

Pursuant to the agreement, pending litigation will be dismissed. Other details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation and sales of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR(R)
2. Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment Sinemet(R)
3. Mylan Schedules Third Quarter 2009 Financial Results Conference Call and Live Webcast
4. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
5. Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
6. Mylan Receives Approval for Generic Version of GoLytely(R)
7. Mylan Declares Quarterly Preferred Stock Dividend
8. Mylan Pre-Pays All Scheduled 2011 Term-Loan Borrowings
9. Mylan Confirms First-to-File Patent Challenge Relating to Vytorin(R) Cholesterol Medication
10. Mylans President of Europe, Middle East and Africa Elected President of European Generic Medicines Association
11. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2017)... , April 19, 2017 The Mobile X-Ray product ... a healthy CAGR during the forecast period Mobile ... the global digital mobile X-Ray devices market, which is estimated ... 2017, expanding at a CAGR of 7% over the forecast ... opportunity of more than US$ 100 Mn in 2017 over ...
(Date:4/19/2017)... DALLAS , April 19, 2017  Vanderbilt University ... first patients in Nashville , Tennesse ... Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) trial. ... to provide long-term reflux control by restoring normal function ... nearly 65 million people in the United ...
(Date:4/19/2017)... 19, 2017  New research provides evidence that an old ... to a study released today that will be presented at ... in Boston , April 22 to 28, ... of Parkinson,s disease, the oral drug levodopa has long been ... But as the disease progresses, the effects of the medication ...
Breaking Medicine Technology:
(Date:4/28/2017)... San Diego, Ca (PRWEB) , ... April 28, 2017 , ... ... the property management industry in the coastal communities. After Tina Howe joined the team, ... healthy and happy employees, honest services at affordable rates, and giving back to the ...
(Date:4/28/2017)... ... April 28, 2017 , ... Researchers ... study of ActiGraph’s CentrePoint Data Hub in a sample of participants ... clinical-grade wearable activity and sleep monitoring solutions for the global scientific community. The ...
(Date:4/28/2017)... ... April 28, 2017 , ... Intellitec Solutions announced ... Foundation implement a Microsoft Dynamics GP solution that integrates to their PointClickCare EHR ... specializes in long-term care, Brooke Grove now has the capability to achieve its ...
(Date:4/28/2017)... ... April 28, 2017 , ... NuevaCare, a leading home care agency ... Burlingame, and Palo Alto, is proud to announce information upgrades to its blog in ... read organized content on topics such as home care (generally) as well as senior ...
(Date:4/28/2017)... ... 28, 2017 , ... Semrock’s highly popular SearchLight Spectra Viewer ... resource for fluorescence microscopists and optical system designers, enabling The Right Solution, Right ... the globe, SearchLight has become a tremendously popular tool for the fluorescence imaging ...
Breaking Medicine News(10 mins):