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:3/24/2017)... , March 24, 2017 Abdominal Aortic Aneurysm Repair Devices Market was ... 2022, Globally, registering a CAGR of 5.1% from 2016 to 2022. The endovascular stent ... dominate the market during the study period. Continue Reading ... ... ...
(Date:3/24/2017)... 2017 New England Pediatric Device Consortium (NEPDC) ... including funding and in-kind service towards the commercialization of ... "Making blood draws less traumatic for children could ... experience better.  We,re looking forward to working with Velano ... care for the kids we treat," said Ann-Christine ...
(Date:3/24/2017)... Research and Markets has announced the addition of the "Global Wound ... report to their offering. ... The global wound care market was worth $24,482.9 million in 2015 and ... Among the various wound care products type, the advanced wound ... 2015. Among the various applications, surgical wound segment held the largest share ...
Breaking Medicine Technology:
(Date:3/25/2017)... ... 2017 , ... Getting earned media coverage meaningful for Garden Media Group's clients ... the year, Garden Media aims to provide material helpful to clients’ goals and bottom ... client’s key messages to gain coveted media placements, Garden Media wows clients year-round. ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... from third world countries to hospitals in the United States, it’s a threat ... on the current obstacles facing infection prevention and offers strategies for the healthcare ...
(Date:3/24/2017)... ... ... The iaedp Foundation, the premier provider of educational programs and training standards for eating ... of disordered eating, announced today that the 2017 Symposium set a new attendance record ... countries converged on the Green Valley Resort in Las Vegas. , “We are ...
(Date:3/24/2017)... ... 24, 2017 , ... Northridge dentists, Dr. Michel ... sleep apnea and TMJ at their office. TMJ, or temporomandibular joint disorder, has ... type, is increasingly being treated at dental offices with newly developed procedures and ...
(Date:3/24/2017)... ... March 24, 2017 , ... Empower Brokerage, located ... training and leads programs. , In February, 2017, Empower Brokerage introduced their new ... Partners is designed to teach how to maximize their sales efforts, as well ...
Breaking Medicine News(10 mins):