Navigation Links
Shire Files Lawsuit Against Mylan for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patent
Date:3/20/2009

PHILADELPHIA, Pennsylvania and DUBLIN, Ireland, March 20 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) announces that it has filed a lawsuit in the U.S. District Court of the Southern District of New York against Mylan Inc., Mylan Pharmaceuticals Inc. and Matrix Laboratories Limited (collectively "Mylan") for infringement of Shire's patent: U.S. Patent No. 5,968,976 ("'976 Patent").

The lawsuit was filed in response to an Abbreviated New Drug Application ("ANDA") filed by Mylan seeking FDA approval to market and sell generic versions of Shire's 500 mg, 750 mg, and 1 g FOSRENOL(R) (lanthanum carbonate) products.

Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Mylan's Paragraph IV notification letter, the FDA must refrain from approving Mylan's ANDA for 30 months, or until a District Court decision finding that the patent is invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire on April 26, 2012 unless terminated earlier.

Shire has asserted the '976 patent based upon information provided to it by Mylan. Shire will continue to evaluate the situation throughout the litigation and will take all necessary actions to protect its rights to the fullest extent possible. Shire has a robust patent estate and is confident that it will protect the FOSRENOL franchise.

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-
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. Shire Files Lawsuit Against Barr Laboratories for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patents
2. Shire Announces Opening of Office in Japan
3. Shire to Enter European ADHD Market With the Acquisition of EQUASYM(R) IR and XL
4. Shire Delivers Excellent Growth for the Year, With the new Product Portfolio Achieving Sales of $1 Billion
5. Shire Receives FOSRENOL Paragraph IV Notice Letters from Barr Laboratories and Mylan
6. Shire plc: Change to Directors Details
7. Shire Successfully Settles Former TKT Shareholder Appraisal Rights Litigation
8. Shires New Product Portfolio Delivers Strong Quarterly Performance
9. Change of Name to Shire plc
10. Shire Announces Holding of 81% in Jerini AG and Publication of Offer Document
11. Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidance Upgrade.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Rootstown, OH (PRWEB) January 22, 2015 Crystal ... announced today that it has received AOAC-PTM Certifications for the ... O111, O121, and O145; collectively referred to as STEC or ... at 1 colony forming unit (cfu) per 325 g of ...
(Date:1/22/2015)... Selexis SA, a serial innovation company with proven ... for drug discovery to commercial manufacturing, announced today all ... Sequencing (NGS) data packages. The NGS analysis of ... the integrity of the gene, validation of the left ...
(Date:1/22/2015)...   GenoSpace , a precision medicine software company that has ... use of genomic, imaging and other biomedical data in research ... Munson , CEO of Aspera, an IBM Company, to its ... http://photos.prnewswire.com/prnh/20150122/170713 "We are pleased to welcome ...
(Date:12/24/2014)... 24, 2014  Vermillion, Inc. (Nasdaq:   VRML), a ... today that the Company closed its previously announced ... Jack W. Schuler , Birchview Fund LLC ... million, before offering expenses.  The proceeds will be ...
Breaking Biology Technology:Crystal Diagnostics Awarded AOAC-PTM Accreditation for the Rapid Detection of “Big 6” E.coli Food Pathogens 2Selexis Generated Research Cell Banks Now Fully Sequenced Using Next-Generation Sequencing 2GenoSpace Expands Board with Appointment of Michelle Munson 2Vermillion Announces Closing of Equity Financing 2Vermillion Announces Closing of Equity Financing 3
... Vasogen Inc.,(NASDAQ: VSGN ; TSX:VAS) today reported the results ... 31, 2008. All dollar amounts referenced,herein are in Canadian ... our cash and cash equivalents totaled $9.8 million,compared with ... loss for the third quarter of 2008 was $2.6 ...
... in Composite Events When Using Routine ... FFR Guidance in Multi-Vessel Disease, WASHINGTON, ... the launch of the PrimeWire(TM) Pressure,Guidewire, and the s5-FFR Option ... in the U.S. The PrimeWire is Volcano,s newest pressure,guidewire, capable ...
... Pillar of Support for National Children,s Program, ... and Chief,Scientific Officer of Tishcon Corp and visionary ... of low income children in,America. In January 2000, ... Patel, and Vice President, Arun Chopra, initiated a,monthly ...
Cached Biology Technology:Vasogen Announces Third Quarter 2008 Results 2Vasogen Announces Third Quarter 2008 Results 3Vasogen Announces Third Quarter 2008 Results 4Vasogen Announces Third Quarter 2008 Results 5Vasogen Announces Third Quarter 2008 Results 6Vasogen Announces Third Quarter 2008 Results 7Vasogen Announces Third Quarter 2008 Results 8Vasogen Announces Third Quarter 2008 Results 9Vasogen Announces Third Quarter 2008 Results 10Volcano Corporation Announces Launch of PrimeWire(TM) Pressure Guidewire and s5-FFR Option for Existing Fleet of s5 IVUS Consoles 2Volcano Corporation Announces Launch of PrimeWire(TM) Pressure Guidewire and s5-FFR Option for Existing Fleet of s5 IVUS Consoles 3Volcano Corporation Announces Launch of PrimeWire(TM) Pressure Guidewire and s5-FFR Option for Existing Fleet of s5 IVUS Consoles 4Volcano Corporation Announces Launch of PrimeWire(TM) Pressure Guidewire and s5-FFR Option for Existing Fleet of s5 IVUS Consoles 5Tishcon Corp Reaches Donation Milestone Exceeds 1 Million Bottles of Multi-Vitamins for Nourish America 2Tishcon Corp Reaches Donation Milestone Exceeds 1 Million Bottles of Multi-Vitamins for Nourish America 3
(Date:1/22/2015)... /PRNewswire/ - Today, FindBiometrics, the leading source of biometrics industry news, ... website design. "When we launched FindBiometrics 12 years ... O,Neill , founder and CEO of FindBiometrics. "Now it,s maturing ... the key players on a very broad scale.  We are ...
(Date:1/22/2015)... Jan. 20, 2015 NXT-ID, Inc. (NASDAQ: NXTD and ... reports on the recent success of the Wocket™ smart wallet at CES ... smart wallet was named as one of the "11 Hot Products at ... Products Launched At CES So Far" by Newseveryday.com and "The top 10 ...
(Date:1/22/2015)...   EyeLock, Inc. , a market leader of iris-based identity ... to the new role of Senior Vice President of ... of mobile platforms and wearable solutions for EyeLock,s technologies. Gerber ... the semiconductor industry to his role at EyeLock, with expertise ...
Breaking Biology News(10 mins):Identity Industry Leading Publication Debuts New Look As Biometrics Hit Mainstream 2CES Response for NXT-ID's Wocket Smart Wallet Kicks Off 2015 2CES Response for NXT-ID's Wocket Smart Wallet Kicks Off 2015 3EyeLock Names Steve Gerber as Senior Vice President of Mobile and Wearables 2
... great debate has raged over whether organic compounds and ... meteorite Allan Hills 84001 were processed by living creatures ... been under intense scrutiny ever since. Scientists at the ... fresh look at how material associated with carbonate globules ...
... concerns that hamper embryonic stem cell research, but they still ... with which adult stem cells differentiate into mature tissue the ... impossible for researchers to multiply them in the laboratory. And ... difficult to use them for treating disease. , Now, ...
... and Infectious Diseases (NIAID), part of the National Institutes ... anthrax toxin that worked well in small-scale animal tests. ... anthrax antitoxin is an important advance, not only for ... also because this technique could be used to design ...
Cached Biology News:Relic of life in that Martian meteorite? A fresh look 2Powerful technique for multiplying adult stem cells may aid therapies 2Powerful technique for multiplying adult stem cells may aid therapies 3Scientists design potent anthrax toxin inhibitor 2Scientists design potent anthrax toxin inhibitor 3
... PEP-152 is a 17 amino acid synthetic peptide whose sequence is ... (amino to carboxy terminus): C - N(217) - Q - ... - A - T - P - N - Y - ... may be used for neutralization and control experiments with the polyclonal ...
... a novel target for which no antibody exists? ... custom antibodies for a variety of pharmaceutical, biotech ... to put our technology and expertise in antibody ... to our patented RabMAb development technology , High ...
... The Rapid-Screen cDNA Library Panels were ... just three sets of PCRs to identify ... analysis is performed in a 96-well "Master ... from 5,000 clones. Having identified the positive ...
... The Rapid-Screen cDNA Library Panels were ... just three sets of PCRs to identify ... analysis is performed in a 96-well "Master ... from 5,000 clones. Having identified the positive ...
Biology Products: