Navigation Links
Shire Files Lawsuits Against Watson and Roxane for Infringement of VYVANSE(R) (lisdexamfetamine dimesylate) Patents
Date:7/7/2011

DUBLIN, July 7, 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 Roxane Laboratories, Inc., ("Roxane"), and in the U.S. District Court for the Central District of California against Watson Laboratories, Inc., ("Watson"), respectively, for infringement of certain of Shire's VYVANSE patents.

The lawsuits were initiated in response to Abbreviated New Drug Applications ("ANDAs") filed by each of Roxane and Watson 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 Roxane and Watson ANDAs before August 23, 2014, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.

Shire will provide details of any additional Paragraph IV certifications received advising of ANDA filings on VYVANSE, and any litigation that is subsequently initiated, in its periodic filings on Forms 10-Q and 10-K.

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)    +44-1256-894157

Media    
Jessica Mann (jmann@shire.com)    +44-1256-894-280    
Matthew Cabrey (mcabrey@shire.com)    +1-484-595-8248



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

Related biology technology :

1. Shire Presents Data at ACMG for Fabry and Gaucher Patients Who Switched to Replagal® (agalsidase alfa) and VPRIV® (velaglucerase alfa for injection)
2. Shire Reports Positive Signal Finding Study of Investigative Use of Vyvanse(R) (lisdexamfetamine dimesylate) Capsules as Adjunctive Treatment in Major Depressive Disorder
3. Shire plc: Continued Excellent Performance in Q3, Full Year Earnings Expectations Increased, New Value in Pipeline Emerging
4. Shire Announces Results of the Tender Offer for Movetis NV and Commencement of Squeeze-Out Tender Period
5. Reportlinker Adds Shire plc: PharmaVitae Profile
6. Shire Announces European Approval of VPRIV(R) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease
7. Shire plc - Statement re ProAmatine
8. Shire Proposes to Expand Specialist Gastrointestinal Portfolio
9. Lialda(R) - Shire Files Suit Against Cadila Healthcare Limited, Doing Business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc.
10. Shire Receives CHMP Positive Opinion for VPRIV(TM) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
11. Shire plc Appoints Two New Board Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/6/2016)... ... December 06, 2016 , ... ... largest privately-held contract pharmaceutical development and manufacturing organisation, today announced the ... company combining a leading CRO and the industry’s only Contract Commercial Organization ...
(Date:12/6/2016)... ... December 06, 2016 , ... Clinical Supplies ... has acquired the assets of Theorem Clinical Research - Clinical Supplies ("TCS"). ... trial drug packaging, labeling, storage, reconciliation, and distribution for pharmaceutical trials across ...
(Date:12/6/2016)... 6, 2016  The Texas Medical Center ... (HISA) today announced the establishment of a new ... Australia and the Texas Medical ... HISA and the Texas Medical Center, with ... create a global health innovation ecosystem where emerging technologies ...
(Date:12/5/2016)... Research and Markets has announced the addition of ... to their offering. ... , This report describes ... such as proteomics and metabolomics. Molecular diagnostics technologies are used for ... biomarker. Currently the most important applications of biomarkers are ...
Breaking Biology Technology:
(Date:11/24/2016)... , Nov. 23, 2016 Cercacor today introduced ... and their trainers non-invasively measure hemoglobin, Oxygen ... Rate, and Respiration Rate in approximately 30 seconds. Smaller ... easy and immediate access to key data about their ... a training regimen. Hemoglobin carries oxygen ...
(Date:11/22/2016)... 2016   MedNet Solutions , an innovative SaaS-based ... clinical research, is pleased to announce that the company ... Life Sciences Awards as "Most Outstanding in eClinical ... year of recognition and growth for MedNet, which has ... iMedNet ™ , MedNet,s flagship ...
(Date:11/19/2016)... , Nov. 18, 2016 Securus Technologies, a ... for public safety, investigation, corrections and monitoring, announced today ... competitor, ICSolutions, to have an independent technology judge determine ... most modern high tech/sophisticated telephone calling platform, and the ... that they do most of what we do – ...
Breaking Biology News(10 mins):