Navigation Links
Mylan Confirms First-to-File Patent Challenge Relating to Lescol(R)
Date:10/22/2008

PITTSBURGH, Oct. 22 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.

Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the product. The company filed an ANDA with the U.S. Food and Drug Administration (FDA) in June. Novartis filed a lawsuit Oct. 10 in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,354,772.

Fluvastatin Capsules, used in the treatment of high cholesterol, had approximately $60 million in sales for the twelve months ending June 30, 2008, according to IMS Health.

Currently, Mylan has 108 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit http://www.mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to the expected first to file status and pending litigation. 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: the use of legal, regulatory and legislative 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 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©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Mylan Launches First Generic Version of Antihypertensive Sular(R) ER in the United States
2. Mylan Announces Final FDA Approval for Ropinirole Hydrochloride Tablets
3. Mylan Announces Amendment to Bystolic(TM) (Nebivolol) Agreement
4. Mylan Announces Final FDA Approval for Balsalazide Disodium Capsules
5. Mylan Announces Tentative FDA Approval for Lamotrigine Tablets
6. Mylan Announces Appointment of Steven G. Zylstra as Vice President of Global Corporate Communication and Public Relations
7. Mylan Inc. Subsidiary, Dey, L.P., Announces that Perforomist(TM) (Formoterol Fumarate) Inhalation Solution is Now Available for Maintenance Treatment of COPD
8. Mylan to Host Investor Day on October 3, 2007
9. Mylan Announces Pricing of Tender Offers for its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015
10. Chromos obtains interim order in connection with arrangement, announces annual and special meeting of shareholders and confirms mailing of information circular
11. Barr Confirms Patent Challenge of Sensipar(R) Tablets, 30mg, 60mg and 90mg
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/10/2017)... (PRWEB) , ... August 09, 2017 , ... ... to help the agriculture industry reach its ideal customers with the right message. ... nation. , “As a Midwest company, we realize how crucial the agriculture industry ...
(Date:8/10/2017)... ... August 09, 2017 , ... ... applications in the clinic is here. The team at Capricor Therapeutics, Inc. utilized ... medium for clinical studies. , Dr. Travis Antes, head of analytical development ...
(Date:8/10/2017)... ... August 09, 2017 , ... Okyanos Center for Regenerative Medicine has announced ... Bay Hotel in Freeport, Grand Bahama on September 27, 2017. This daytime event is ... oversight from the Ministry of Health’s National Stem Cell Ethics Committee (NSCEC) and regulations ...
(Date:8/10/2017)... ... August 10, 2017 , ... DrugDev and the Society for ... demonstrate how Good Clinical Practice (GCP) can be used throughout the site activation process ... discuss the importance of GCP compliance, how sites are affected by GCP during selection ...
Breaking Biology Technology:
(Date:3/29/2017)... -- higi, the health IT company that operates the largest ... , today announced a Series B investment from BlueCross ... new investment and acquisition accelerates higi,s strategy to create ... health activities through the collection and workflow integration of ... and secures data today on behalf of over 36 ...
(Date:3/27/2017)... 27, 2017  Catholic Health Services (CHS) has ... Society (HIMSS) Analytics for achieving Stage 6 on ... . In addition, CHS previously earned a place ... an electronic medical record (EMR). "HIMSS ... of EMR usage in an outpatient setting.  This ...
(Date:3/24/2017)... , Mar 24, 2017 Research and ... Access System Market Analysis & Trends - Industry Forecast to 2025" ... ... to grow at a CAGR of around 15.1% over the next ... This industry report analyzes the market estimates and forecasts for all ...
Breaking Biology News(10 mins):