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
'/>"/>

SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

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:1/23/2015)... lot of discussion in the medical community revolves around figuring ... conditions. As medical science advances, doctors and surgeons often feel ... consider to be more cutting edge. Yet, when it comes ... treatment that stands out as the best solution in all ...
(Date:1/23/2015)... , Jan. 23, 2015  MedScope ( www.medscope.org ), ... nominated for a 2015 Connected World magazine ... Response System (mPERS), that can be used anywhere, anytime. ... partner.  In nominating MedScope, Landon ...
(Date:1/23/2015)... , Jan. 23, 2015  HyGreen, Inc., a leader ... and partnership with RCA Medical, a subsidiary of Ascendis ... . Each year, hundreds of millions of ... infections as organisms are transmitted from patient to patient ...
Breaking Medicine Technology:No One-Size-Fits-All Remedy for Hernia Correction 2MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2HyGreen Partners with RCA Medical in Johannesburg, South Africa 2
... , , , , ... , , DES PLAINES, Ill., Sept. 10 ... program to support fresh and creative research ideas for solving the challenges of ... have been some significant scientific breakthroughs over the past decade resulting in better ...
... , EMERYVILLE, Calif., Sept. 10 ... http://www.novabaypharma.com ), a clinical stage company developing novel ... range of bacterial, viral and fungal infections, announced today the ... Aganocide(R) compound NVC-422 in impetigo. , , ...
Cached Medicine Technology:American Brain Tumor Association Calls for Discovery Research 2NovaBay Launches Clinical Study for Non-Antibiotic Treatment of Impetigo, One of the Most Common Skin Infections 2NovaBay Launches Clinical Study for Non-Antibiotic Treatment of Impetigo, One of the Most Common Skin Infections 3NovaBay Launches Clinical Study for Non-Antibiotic Treatment of Impetigo, One of the Most Common Skin Infections 4
(Date:1/22/2015)... Bradley, Illinois (PRWEB) January 22, 2015 Deer ... -- will host a Valentine’s Day Happy Hour from 3 p.m. ... located at 12500 Regency Parkway in Huntley, Illinois, serves adults with ... Happy Hour event will include Valentine's Day treats, games and sweetheart-themed ...
(Date:1/22/2015)... The City of West Hollywood hosted a news conference on ... anniversary of the Supreme Court decision Roe v. Wade, which legalized ... the Roe vs. Wade decision and the fight to protect a ... City of West Hollywood Councilmember Abbe Land. “We need to continue ...
(Date:1/22/2015)... (PRWEB) January 23, 2015 VogueQueen is a ... affordable prices and many designers are thrilled to have it ... business announces its new collection of prom dresses for the ... to drive the strategic vision and he focuses on continuing ...
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, ... dresses. View website of AngelWeddingDress.com to find ... wedding dresses online for a bridal party. AngelWeddingDress offers ... for them. Its maternity wedding dresses are specially designed ...
(Date:1/22/2015)... York, New York (PRWEB) January 22, 2015 ... filed after Fresenius Medical Care recalled its GranuFlo and ... federal multidistrict litigation underway in U.S. District Court, District ... Order dated January 20th, the Court has remanded a ...
Breaking Medicine News(10 mins):Health News:Deer Path of Huntley Affordable Assisted Living to Host Valentine's Day Happy Hour 2Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4
... Central Government of India has now issued a list ... reference standards or grades that should be followed in ... list was issued after a number of reports claimed ... basis had developed adverse effects. ,The substances ...
... opt for mercy killing// in Netherlands. ,New ... may have the choice of mercy killing in Dutch. ... guidelines which is called as Groningen Protocol to be ... Society accepted that "in exceptional circumstances and under strict ...
... menopause that gets eliminated during the hormone replacement therapy// ... discontinued. ,Hormone replacement therapy is the treatment procedure ... also known as synthetic progesterone. At times the treatment ... surgical removal of their uterus. HRT is often used ...
... it helps if the donors// and the recipients sit in front ... research by the Cardiff University investigators it had come to light ... their donors as they feel they would personally like to ensure ... the donor’s health. ,The donors on the other hand had ...
... a potent narcotic medication for pain management// is under FDA ... were reported. The FDA says it is conducting an investigation ... unclear if the deaths are due to inappropriate use of ... product. ,Deaths and overdoses have occurred in patients using ...
... initiative a railway station – Ongole town in Andhra Pradesh ... not only broadcast arrival and departures of trains but also ... safe sex. Andhra Pradesh in India has high incidence of ... current generation is racing towards HIV/AIDS like mad. I witness ...
Cached Medicine News:
... manufacturers a wide variety ... (also known as "Reverse ... Lenses) according to the ... standards of orthokeratology practitioners ...
... These are rigid gas permeable contact lenses ... that temporarily corrects nearsightedness (myopia). The patient ... removes them upon wakening. During the day, ... Paragon CRT and Quadra RG contact lenses ...
... for a way to help your patients ... disease? Based on the outcomes of ... (ECP) has improved the quality of their ... normal activities of daily living. , ,MedCath ...
... lab? Worried about the high costs, start-up ... of managing the ongoing business operations? As ... leaving you free to care for your patients., ... convenient diagnostic facility for you and your patients. ...
Medicine Products: