Navigation Links
Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
Date:2/4/2010

PITTSBURGH, Feb. 4 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg. This product is the generic version of Caduet® Tablets, which combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 2.5/10 mg, 2.5/20 mg, 2.5/40 mg and 10/40 mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Pfizer filed the lawsuit in the U.S. District Court for the District of Delaware.

Caduet Tablets had approximately $65.6 million in sales for the 2.5/10 mg, 2.5/20 mg, 2.5/40 mg and 10/40 mg strengths for the twelve months ending Dec. 31, 2009, according to IMS Health. Currently, Mylan has 142 ANDAs pending FDA approval representing $87.5 billion in annual brand sales, according to IMS. Forty of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, according to IMS.

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.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 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, please visit www.mylan.com.

SOURCE Mylan Inc.

RELATED LINKS
http://www.mylan.com

'/>"/>

SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Receives Approval for Generic Version of GoLytely(R)
2. Mylan Declares Quarterly Preferred Stock Dividend
3. Mylan Pre-Pays All Scheduled 2011 Term-Loan Borrowings
4. Mylan Confirms First-to-File Patent Challenge Relating to Vytorin(R) Cholesterol Medication
5. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
6. Mylan Added to NASDAQ-100 Index
7. Mylan Receives Approval for Generic Version of Antiepileptic Keppra(R) 1000 mg
8. Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR(R)
9. Mylans President of Europe, Middle East and Africa Elected President of European Generic Medicines Association
10. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
11. Mylan Schedules Third Quarter 2009 Financial Results Conference Call and Live Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., ... analytics, today announced that it has been ranked #1 by ... Black Book™ Rankings 2017 User Survey. ZirMed was recognized ... for large hospitals and medical centers over 200 beds and ... Book,s healthcare technology user survey history. ...
(Date:9/18/2017)... PROVIDENCE, R.I. , Sept. 18, 2017 ... in the fields of bioinformatics and immune ... to develop a protective avian influenza A (H7N9) vaccine. ... is distantly related to seasonal influenza and ... approaches, which rely on prior exposure to be ...
(Date:9/12/2017)... and NEW YORK , Sept. 12, 2017 ... performance ratings for global supply chains, has published the first annual edition ... CSR performance of more than 20,400 companies evaluated by EcoVadis, based on ... 2015 and 2016. ... EcoVadis Global CSR Risk & Performance Index ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... While it’s often important to take certain medications during ... Austin, Texas, has identified a solution. , She developed a prototype for MOTION LIGHT-UP ... such, it eliminates the need to turn on a light when taking medication during ...
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & Associates ... special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to date ... elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded by ...
(Date:10/13/2017)... ... , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many ... event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids ... of all ages; it is a non-competitive, non-timed event, which is all about having ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the ... published author, William Nowers. Captain Nowers and his wife, Millie, have six children, ... in the Navy. Following his career as a naval aviator and carrier pilot, ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... introduction of an innovative new design of the shoulder pad. The shoulder pad ... comfort while controlling your pain while using cold therapy. By utilizing ice and water ...
Breaking Medicine News(10 mins):