Navigation Links
Shire Files Lawsuits Against Sandoz and Amneal for Infringement of VYVANSE® (lisdexamfetamine dimesylate) Patents

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'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:


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 ( +1-781-482-0999 Sarah Elton-Farr ( +44(0)1256-894157 Media Jessica Mann ( +44(0)1256-894-280 Matthew Cabrey ( +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:
(Date:11/26/2015)... North Carolina , 26 november 2015 ... Inc. (AAIPharma/CML) kondigt de geplande investering aan ... uitbreiding van de laboratoria en het mondiale ... . De uitbreiding zal resulteren in extra ... wordt voldaan aan de groeiende behoeften van ...
(Date:11/26/2015)... , Nederland, November 26, 2015 ... Een nieuwe aanpak combineert immunotherapie met ... kanker. ) ...      (Photo: ) ... Leids Universitair Medisch Centrum (LUMC) ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ) ... Pacemaker Market Outlook to 2019 - Rise in Cardiac Disorders ... report to their offering. Boston ... Boston scientific and others. --> ... Biotronik, Boston scientific and others. ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... ... According to an article published November 15th by ABC News, while ... light of the recent terrorist attacks in Paris, other cities are taking extra precautions ... reaching U.S. soil. Especially around special events that may be high-profile in nature, the ...
(Date:11/27/2015)... ... November 27, 2015 , ... A team of Swiss ... to treat it. Surviving Mesothelioma has just posted the findings on the website. ... Zurich analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy followed ...
(Date:11/27/2015)... ... November 27, 2015 , ... "When I ... an inventor from Hillside, N.J. "Many people catch diseases simply from sitting on ... will always be protected from germs." , He developed the patent-pending QUDRATECS to ...
(Date:11/27/2015)... ... November 27, 2015 , ... The print component of ... in Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation of approximately ... nationally, through a vast social media strategy and across a network of top ...
(Date:11/27/2015)... , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community in the ... Table 1-1 ). More than 3.7 billion people under the age of 50 ... (HSV-1), according to WHO's first global estimates of HSV-1 infection . , "The data ...
Breaking Medicine News(10 mins):