Navigation Links
Mylan Announces Settlement Agreement for its First-to-File Generic Version of Vivelle-Dot®
Date:11/21/2011

PITTSBURGH, Nov. 21, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has settled a patent litigation lawsuit with Novartis Pharmaceuticals Corporation related to Vivelle-Dot® (Estradiol Transdermal System USP, Twice-Weekly, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day and 0.075 mg/day and 0.1 mg/day).

Pursuant to the agreement, pending litigation will be dismissed, and Mylan will receive a patent license to begin selling generic versions of the product on Dec. 16, 2013, or earlier under certain circumstances. Additional 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.

Mylan was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System USP, Twice-Weekly. This product had total U.S. sales of $240 million for the 12 months ending Sept. 30, 2011, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.

This press release includes statements that constitute "forward-looking statements," including with regard to the settlement and the marketing 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.


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

Related medicine technology :

1. Mylan Successfully Upsizes and Completes Refinancing of Credit Facility
2. Mylan Applauds Obama Administrations Call to Create an "AIDS-Free Generation" Through Global Fight Against HIV/AIDS
3. Mylan to Acquire Pfizer Respiratory Delivery Platform
4. Mylan Receives Approval for Generic Version of MS Contin® Tablets
5. Mylan Launches First Generic Version of Exelon® Capsules in the U.K.
6. Mylans Dey Pharma Successfully Obtains Patent Reexamination Certificates for Two Perforomist® Patents
7. Matrix Laboratories Completes Name Change to Mylan Laboratories
8. Mylan Announces Femcon® Fe Settlement Agreement
9. Mylan Announces Intention to Refinance Existing Secured Credit Facility
10. Mylan Comments on Death of Company Co-Founder and Former Chairman and CEO Milan "Mike" Puskar
11. Mylan Applauds Study Highlighting $931 Billion in Savings for U.S. Health Care System Due to Generic Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... One of Australia,s successful biotechnology ... a new biotechnology company, Noxopharm Limited [ABN 50 608 966 123] ... to list on the ASX. Noxopharm is a clinic-ready ... a Phase 1 clinical study later this year. ... the biggest problems facing cancer patients - the ability of cancers ...
(Date:6/26/2016)... , June 27, 2016 Jazz Pharmaceuticals plc ... period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, ... of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ... (Eastern Daylight Time). As previously announced on ... a definitive merger agreement under which Jazz Pharmaceuticals has ...
(Date:6/26/2016)... June 27, 2016  VMS Rehab Systems, Inc. ( ... take whatever measures required to build a strong and ... is currently listed on the OTC Markets-pink current trading ... and CEO, "We are seeing an anomaly in market ... not only by the Company, but shareholders and market ...
Breaking Medicine Technology:
(Date:6/25/2016)... FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial ... Plant City Observer , brings up a new, often overlooked aspect of head lice: the ... closing for fumigation is not a common occurrence, but a necessary one in the event ...
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief ... a minimum wage raise to $12 an hour by 2020 and then adjusting it yearly ... lost value of the minimum wage, assure the wage floor does not erode again, and ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Frederick area economy by obtaining investment capital for emerging technology companies. ... years that have already resulted in more than a million dollars of capital ...
Breaking Medicine News(10 mins):