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 re
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

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:5/23/2013)... 23, 2013 Virobay, Inc. today announced that ... reached an important milestone, as Virobay has now initiated ... selective cathepsin S inhibitor.   The first ... placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics ... adults. "The initiation of this Phase 1 ...
(Date:5/23/2013)... Northwest Biotherapeutics (NASDAQ: NWBO ) ... personalized immune therapies for solid tumor cancers, announced today ... American Society Of Clinical Oncology (ASCO) meeting in ... in immune therapy.  (Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO ) ... pre-eminent conference focused on clinical treatment of cancer, with ...
(Date:5/23/2013)... 2013 During the conduct of ... adhere to principles of good clinical practice (GCP) ... Dr. Jeremy Lim, Fellow, Clinical Development at Novartis ... ,     Understand the International Conference on Harmonization (ICH) ... regulations for the conduction of clinical trials , ...
(Date:5/23/2013)... May 23, 2013 Bed bugs already cost ... pests is still ongoing, a report from kmov.com suggested that ... the bed bug treatment. Meanwhile, to be of help, My ... the costly bed bug exterminator service. , The ... AHA has so far spent $35,000 for bed ...
Breaking Biology Technology:Virobay, Inc. initiates a Phase 1 Trial of VBY-036, a compound intended for the treatment of neuropathic pain 2Virobay, Inc. initiates a Phase 1 Trial of VBY-036, a compound intended for the treatment of neuropathic pain 3NW Bio Exhibit at the Upcoming ASCO Meeting to Highlight its Leadership Role in Immune Therapy for Cancer 2NW Bio Exhibit at the Upcoming ASCO Meeting to Highlight its Leadership Role in Immune Therapy for Cancer 3Adhering to Good Clinical Practice, New Webinar Hosted by Xtalks 2Bed Bug Exterminator Service Could Cost AHA $250K, My Cleaning Products Gives Tips How to Save Apartments from Costly Bed Bug Treatment 2
... vein treatment methods led by Dr. Sinjae Hyun, associate professor of biomedical ... he will present this summer to his research collaborators and the company. ... ... California company aided in the research of vein treatment methods ...
... Therapeutics, Inc. (CTI),(Nasdaq and MTA: CTIC) announced today ... accepted for filing and review, and has granted,priority ... for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation,therapy ... achieve,a response to first-line therapy. Priority review is ...
... ENCO ), a full service multinational clinical ... many of the world,s leading,pharmaceutical and biotechnology companies, today ... from Nasdaq stating that since it had not yet,filed ... 2008 as of the,date of the letter, it was ...
Cached Biology Technology:Gift Aids Professor's Research into Vein Treatment 2Gift Aids Professor's Research into Vein Treatment 3Gift Aids Professor's Research into Vein Treatment 4FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review 2FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review 3FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review 4FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review 5Encorium Announces Receipt of Letter from Nasdaq Regarding its Third Quarter 2008 Form 10-Q Filing 2Encorium Announces Receipt of Letter from Nasdaq Regarding its Third Quarter 2008 Form 10-Q Filing 3
(Date:5/22/2013)... 22, 2013)The omega 3 fatty acids in fish oil ... much so that the American Heart Association currently recommends ... particularly fatty varieties rich in omega 3s. However, the ... In a new study, scientists led by Jason R. ... phenomenon by providing evidence that fish oil might specifically ...
(Date:5/22/2013)... how climate change will affect interactions between species in ... of Animal Ecology . This knowledge, they say, is ... how species are likely to be impacted by rising ... among biologists that climate change is affecting how species ... to have very important consequences for the stability and ...
(Date:5/21/2013)... device attached to a whale entangled in fishing gear, ... changed a whale,s diving and swimming behavior. The monitoring ... and migrate, depletes their energy as they drag gear ... slow death. , The scientists in this entanglement response ... two-year-old female North Atlantic right whale called Eg 3911. ...
Breaking Biology News(10 mins):Fish oil may help the heart beat mental stress 2UCLA life scientists present new insights on climate change and species interactions 2UCLA life scientists present new insights on climate change and species interactions 3UCLA life scientists present new insights on climate change and species interactions 4UCLA life scientists present new insights on climate change and species interactions 5Study reveals how fishing gear can cause slow death of whales 2Study reveals how fishing gear can cause slow death of whales 3
... University of Akron researcher is leveraging advanced modeling ... organic materials bond to inorganic materials, a natural ... design of composite materials and devices for such ... generation and treatment of diseases. Hendrik Heinz, ...
... December, 2010 Elsevier, the world-leading publisher of scientific, ... that it is participating in the recently launched Google ... eBook titles. Elsevier regards Google eBooks as a valuable ... its scientific and professional ebook content in the United ...
... Diving blue whales can dive for anything up to ... Columbia, Canada, explains that blue whales may be able to ... could carry in their blood and muscles, so why don,t ... water must use a lot of energy, says Shadwick. Explaining ...
Cached Biology News:Simulations aim to unlock nature's process of biomineralization 2Elsevier offers scientific book content through Google eBooks 2Blue whale-sized mouthfuls make foraging super efficient 2
Mouse monoclonal antibody raised against a partial recombinant NEK2. NCBI Entrez Gene ID = NEK2...
... Minis 300V power supply (Cat. No. Minis ... sufficient for SDS-PAGE, and native PAGE applications. ... of terminator pairs can be used simultaneously. ... individuals to have his/her own power supply ...
... premium quality recombinant form of Thermus aquaticus ... for a wide range of PCR applications. ... performance, each preparation is extensively tested in ... DNA Polymerase possesses an integral 5′→3′ exonuclease ...
Mouse monoclonal antibody raised against a partial recombinant COG2. NCBI Entrez Gene ID = COG2...
Biology Products: