Navigation Links
Shire Files Lawsuits Against Sandoz and Amneal for Infringement of VYVANSE® (lisdexamfetamine dimesylate) Patents
Date:7/1/2011

DUBLIN, July 1, 2011 /PRNewswire/ --


 

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has filed lawsuits in the U.S. District Court for the District of New Jersey against each of Amneal Pharmaceuticals, LLC ("Amneal") and Sandoz, Inc. ("Sandoz") for infringement of certain of Shire's VYVANSE patents.

The lawsuits were initiated in response to Abbreviated New Drug Applications ("ANDAs") filed by Amneal and Sandoz seeking FDA approval to market and sell generic versions of all currently approved doses of VYVANSE.

Under the Hatch-Waxman Act, the FDA must refrain from approving the Sandoz and Amneal ANDAs for 30 months (expiring August 23, 2014), or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFEHARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceuticals and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

For further information please contact:

Investor Relations Eric Rojas (erojas@shire.com) +1-781-482-0999 Sarah Elton-Farr (seltonfarr@shire.com) +44(0)1256-894157 Media Jessica Mann (jmann@shire.com) +44(0)1256-894-280 Matthew Cabrey (mcabrey@shire.com) +1-484-595-8248


'/>"/>
SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. United Lincolnshire Hospitals NHS Trust Selects Jayex QI Interactive Patient Survey and Information Management Kiosk
2. Shire Completes Acquisition of Advanced BioHealing, Inc.
3. European Authorities Approve New Manufacturing Facility for Shires REPLAGAL® (agalsidase alfa)
4. Prasco Announces Agreement with Shire for Future Exclusive Distribution and Supply of Authorized Generic for PENTASA®
5. Shire Recognized by ISPE Facility of the Year Awards Program
6. Reportlinker Adds Shire plc: PharmaVitae Profile
7. Shire Presents Positive New Data at the 60th Annual American Society of Human Genetics (ASHG) for Patients with Type 1 Gaucher Disease
8. Shire plc: Third Quarter 2010 Results Date Notification - October 29, 2010
9. Atrium Recognized by New Hampshire Bio/Medical Council
10. Shire Update on ProAmatine(R) (midodrine HCl)
11. Shire Announces Support for Inflammatory Bowel Disease (IBD) Fellowships at Leading Medical Institutions Nationwide
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... Dec. 5, 2016  New research by the ... Institute and the U.S. Department of Health and ... Preparedness and Response (ASPR), published online today in ... pharmacy notifications encourage patients with chronic conditions to ... The study also affirms that public-private partnerships can ...
(Date:12/5/2016)... Dec. 5, 2016  BD (Becton, Dickinson and Company) ... technology company, will demonstrate an enhanced technology platform designed ... including the company,s leading Pyxis™ and Alaris™ systems, at ... 2016 Midyear Meeting being held in ... While national data show that approximately 68 percent of ...
(Date:12/5/2016)... 5, 2016 Research and Markets has announced the ... Forecast to 2021" report to their offering. ... , , The global ... by 2021, at a CAGR of 5.3% from 2016 to 2021. Factors ... obesity cases, increasing government spending on healthcare, and rising income levels are ...
Breaking Medicine Technology:
(Date:12/5/2016)... ... , ... Sideline Products is a Southern York County Pennsylvania-based premier designer and ... the horse. Smaller saddles can pinch and irritate the horse creating safety issues and ... fitted western saddle so it does not impact the comfort or performance of the ...
(Date:12/5/2016)... ... December 05, 2016 , ... Airy Jeanine ... with prolific Songwriter-Producer Corey “Chorus” Gibson who has worked on hits by mega-artists ... a few.     https://twitter.com/coreychorus , The sessions taking place in North Jersey’s ...
(Date:12/5/2016)... ... , ... As renowned, board-certified dermatologists, Dr. Sabrina G. Fabi and Dr. Douglas ... not do their research and undergo cosmetic dermatology treatments from unqualified practitioners or worse, ... renaissance and every other month a new treatment or device is launched, promising everlasting ...
(Date:12/5/2016)... Columbus, OH (PRWEB) , ... December 05, 2016 ... ... novel engineering solution called the CardioQuick Patch® significantly improves the reproducibility and accuracy ... usability in various healthcare settings. , Over the last 60 years, studies ...
(Date:12/4/2016)... , ... December 03, 2016 , ... While James Earl ... serving as host for in a show called "Front Page". One of the forthcoming ... years, breast cancer rates have plummeted in large part due to early detection. Like ...
Breaking Medicine News(10 mins):