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:5/3/2016)... New York, NY (PRWEB) , ... May 03, ... ... and NeuroTech NYC , the sensor and data driven conferences, will take ... include:, UnitedHealth's Vidya Raman-Tangella on incorporating technology -- ...
(Date:5/3/2016)... Calif (PRWEB) , ... May 03, 2016 , ... ... industry leading fertility clinics and IVF laboratories. A contingency of reproductive endocrinologists, including ... treat men and women experiencing infertility and to help them build families. , ...
(Date:5/2/2016)... ... May 02, 2016 , ... F.E.E.D. Co., the ... of their revolutionary, veterinarian-designed product for indoor cats. The NoBowl Feeding System replaces ... their food the way nature intended. NoBowls make cats happy and healthy. , ...
(Date:4/29/2016)... , April 29, 2016 ... Transparency Market Research "Separation Systems for Commercial Biotechnology ... Trends, and Forecast 2015 - 2023", the separation ... US$ 10,665.5 Mn in 2014 and is projected ... 2015 to 2023 to reach US$ 19,227.8 Mn ...
Breaking Biology Technology:
(Date:3/15/2016)... 2016 --> --> ... Market Research "Digital Door Lock Systems Market - Global Industry ... the global digital door lock systems market in terms of ... is forecast to grow at a CAGR of 31.8% during ... medium enterprises (MSMEs) across the world and high industrial activity ...
(Date:3/11/2016)... March 11, 2016 http://www.apimages.com ) - ... Picture is available at AP Images ( http://www.apimages.com ) - ... be used to produce the new refugee identity cards. DERMALOG will ... at CeBIT in Hanover next week.   ... will be used to produce the new refugee identity cards. DERMALOG ...
(Date:3/9/2016)... YORK , March 9, 2016 This ... and future states of the RNA Sequencing (RNA Seq) ... segments such as instruments, tools and reagents, data analysis, ... Analyze various segments of the RNA-Sequencing market such as ... services Identify the main factors affecting each segment and ...
Breaking Biology News(10 mins):