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:5/27/2020)... (PRWEB) , ... May 27, 2020 , ... ... that Jeffrey Taub , a biomedical engineer with more than 25 years ... products, has joined the firm as an Expert Consultant. His expertise includes quality ...
(Date:5/26/2020)... , ... May 26, 2020 , ... SignatureCare Emergency Center, ... of Pflugerville, TX . , The new ER is set to open early June, ... School Road at 21315 N SH 130, Bldg.4, Pflugerville, TX. , According to ...
(Date:5/25/2020)... ... ... Federal data has already confirmed that most of the deadly victims of COVID-19 in ... that many of those who have died from the virus were also denied tests. ... an artist that calls himself The Undiscovered Artist brings light to this matter in ...
Breaking Medicine Technology:
(Date:5/21/2020)... ... May 21, 2020 , ... ... its first milestone to deliver over one million FDA-compliant face shields — designed, ... Face Shields meet the critical need for personal protective equipment (PPE) for both ...
(Date:5/21/2020)... ... May 21, 2020 , ... In response ... be lifted on May 28th and all businesses will be required to have ... back to work. , As an essential business, AmeriCare Medical began this precautionary ...
(Date:5/21/2020)... , ... May 21, 2020 , ... JNL Technologies ... industry announced the release of the SafeHealth screening software. This tool allows ... need for additional staff or the cost of additional paperwork management. , SafeHealth allows ...
(Date:5/16/2020)... ... ... Dr. Tomasz Biernacki states that “If bunion and flat foot ... can keep the foot from being unable to fit into good supportive shoes in ... develop flat feet and bunion formation can have further knee pain, hip ...
(Date:5/15/2020)... ... , ... As businesses prepare to reopen, preventative measures must be put in ... the spread of the virus in a way that is not intrusive or off-putting ... TempCheck Sentinel and TempCheckplus Sentry no-contact infrared temperature sensing systems. , The TempCheck ...
Breaking Medicine News(10 mins):