Navigation Links
Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R)
Date:10/13/2009

PHILADELPHIA, October 13 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. ("Sandoz") in connection with Sandoz's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR(R) (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder.

The settlement also provides Sandoz with a license to market it own generic versions of ADDERALL XR(R) in the United States beginning upon approval of its own generic products by the FDA, and Sandoz will pay Shire a royalty from those sales. To date, the US Food and Drug Administration has not approved any generic version of ADDERALL XR(R). No payments to Sandoz are involved in the settlement agreement. Impax Pharmaceuticals Inc. and Barr Laboratories Inc. remain the only authorized generic supplier of ADDERALL XR.

The litigation involves a patent infringement lawsuit covering Shire's U.S. patents Nos. 6,322,819 ("the '819 Patent"), and 6,605,300 ("the '300 Patent"). As part of the settlement, Sandoz has agreed to a consent judgment confirming that its proposed generic products infringe Shire's '819 and '300 Patents and that the two patents are valid and enforceable.

Resolution of the case against Sandoz ends all litigation against generic ANDA applicants over ADDERALL XR(R).

The agreements, which are effective immediately, have been submitted to the US Federal Trade Commission for its review as required by law.

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.

"SAFE HARBOR" 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 Pharmaceutical 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         Clea Rosenfeld (Rest of the World) +44-1256-894-160
    Relations
                     Eric Rojas (North America)         +1-617-551-9715
    Media            Jessica Mann (Rest of the World)   +44-1256-894-280
                     Matthew Cabrey (Specialty Pharma)  +1-484-595-8248


SOURCE Shire Plc


'/>"/>
SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Veriscrip and DAMMAD Team Up to Combat Prescription Drug Abuse in New Hampshire
2. New Hampshire Rx Card Launching Statewide
3. Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
4. Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
5. Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
6. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
7. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
8. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
9. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
10. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
11. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... , April 20, 2017 Eyevensys, ... the first non-viral gene expression technology that enables the ... eye to address a wide range of ophthalmic diseases, ... and Healthcare products Regulatory Agency (MHRA) to advance its ... ...
(Date:4/19/2017)... 19, 2017 The Mobile X-Ray product segment is ... CAGR during the forecast period Mobile X-Ray segment ... digital mobile X-Ray devices market, which is estimated to be ... at a CAGR of 7% over the forecast period. Mobile ... more than US$ 100 Mn in 2017 over 2016. The ...
(Date:4/19/2017)... April 19, 2017 The Global Effective ... to 2022 report has covered and analysed the potential of ... on market size, shares and growth factors. The report identifies ... and opportunities in the global market. ... Browse 152 Tables and Figures, 6 Major Company ...
Breaking Medicine Technology:
(Date:4/27/2017)... ... April 27, 2017 , ... The ... Rewards, and Recognition: A Nudge Guide," a groundbreaking analysis of how behavioral economics ... takeaways to apply immediately to IRR programs, the report highlights proven behavioral economics ...
(Date:4/27/2017)... ... April 27, 2017 , ... Last night, Christine Collins ... the Year for her extraordinary compassion and lifelong dedication to serve others. Since ... caregivers for the prestigious award each year – identifying a CAREGiver who has ...
(Date:4/27/2017)... ... , ... Are you investing in the safety of your friends and family? ... summer. While most of us assume this type of accident will never happen to ... are taking the time to learn how to respond effectively or prevent these accidents ...
(Date:4/26/2017)... (PRWEB) , ... April 26, 2017 , ... Journal ... adults. It can have severe consequences to overall dental health, including complications with speech, ... often turn to dental implants to replace lost teeth. As the number of tooth ...
(Date:4/26/2017)... ... April 26, 2017 , ... Elisabete Miranda, president and ... by Enterprising Women magazine as one of its 2017 Enterprising Women of the ... Winners have demonstrated that they have fast-growth businesses, mentor or actively support other ...
Breaking Medicine News(10 mins):