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:1/16/2017)... SAN FRANCISCO, Calif. , Jan. 16, 2017 /PRNewswire/ ... that on January 3, 2017 and January 16, 2017 ... the grant of inducement stock options to purchase an ... new employees. These awards were granted pursuant to the ... inducement material to the new employees entering into employment ...
(Date:1/16/2017)... , Jan. 16, 2017 CBDRx, the world,s ... amounts of phyto-nutrient rich hemp extract to Veteran,s groups ... of their proprietary hemp extract to Veteran,s groups across ... best hemp company in the world and through their ... nutritious, full spectrum phyto-nutrient rich hemp extract available. ...
(Date:1/15/2017)... 16, 2017 Le conseil d,administration de ... de collagène pour la régénération de tissus humains, annonce la ... directeur général avec effet immédiat. ... Bill est un dirigeant expérimenté à ... postes de gestion générale et de direction au sein de ...
Breaking Medicine Technology:
(Date:1/16/2017)... , ... January 16, 2017 , ... ... been appointed Chief Executive Officer of the medical device company, effective immediately. , ... Robert Storey. “Kevin has a strong track record in medical device market ...
(Date:1/15/2017)... ... 2017 , ... Going above and beyond the practical impact ... communities around the world by offering the Gensuite team and their services to ... members to become involved in a cause that is bigger than themselves and ...
(Date:1/15/2017)... ... 15, 2017 , ... "On Tour is a music themed slideshow production package ... Christina Austin - CEO of Pixel Film Studios. , On Tour’s new slide ... and animation of their slideshows. Place each slide on top of another slide or ...
(Date:1/15/2017)... ... January 15, 2017 , ... The Gravity Vault Indoor Rock Climbing Gym is ... wraps up on the 14,000+ square foot climbing gym, the owners anticipate to open ... in New Jersey and two in New York. With this being its first location ...
(Date:1/14/2017)... ... January 13, 2017 , ... According to a ... Mediterranean diet may lower the risk of type 2 diabetes, Alzheimer’s, and cardiovascular ... health and wellness benefits linked to a Mediterranean diet are only some of ...
Breaking Medicine News(10 mins):