Navigation Links
Shire Files Lawsuit Against Natco Pharma for Infringement of FOSRENOL(R) (lanthanum carbonate) Patents
Date:4/2/2009

PHILADELPHIA, April 2 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) announces that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Natco Pharma Limited ("Natco") for infringement of two of Shire's patents: U.S. Patent No. 5,968,976 ("'976 Patent"); and U.S. Patent No. 7,381,428 ("'428 Patent");

The lawsuit was filed in response to an ANDA (Abbreviated New Drug Application) filed by Natco 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 Natco's Paragraph IV notification letter, the FDA must refrain from approving Natco's ANDA for 30 months, or until a district court decision finding that the patents are 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 and '428 patents based upon information provided to it by Natco. 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-licensing, merger and acquisition
'/>"/>

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

Page: 1 2

Related biology technology :

1. Shire Appoints Sylvie Gregoire President of Human Genetic Therapies Business
2. Shires ELAPRASE(R) (idursulfase) Approved in Japan for the Treatment of Hunter Syndrome
3. Shire Divests Non-Core Product Portfolio to Almirall
4. Correction: Shire plc: Third Quarter 2007 results date notification November 1, 2007
5. David Mott Appointed Non Executive Director at Shire
6. Shire plc: Board Changes
7. Alba Therapeutics Corporation and Shire plc Enter Into $325 Million ex-US, ex-Japan Licensing Agreement to Develop and Commercialize AT-1001
8. Shire Expands its Gastrointestinal Portfolio Through In-Licensing Celiac Disease Phase 2 Product From Alba Therapeutics Corporation
9. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
10. Texas Boy Receives Wheelchair From New Hampshire Couples Recently Deceased Granddaughter
11. Shire Engages Palio
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... 21, 2014 2014 Deep ... is a professional and in-depth research report ... provides basic Seaweed Fertilizer information, including Seaweed ... structure as well as industry overview. This ... domestic market as well as global industry ...
(Date:8/21/2014)... Emmetsburg, IA (PRWEB) August 21, 2014 ... Project LIBERTY Opening , The Court of His Majesty ... King will attend the Grand Opening of POET-DSM Advanced ... on Wednesday, Sept. 3. , The King will take ... formal opening activity, scheduled for 11 a.m.-12:20 p.m. and ...
(Date:8/21/2014)... The College of New Rochelle announced ... the Mid-Hudson Region to be designated as a START-UP ... from qualified “high-technology” businesses that align with the College’s ... have been selected for the START-UP NY program and ... stimulate economic development in New York by growing business ...
(Date:8/21/2014)... Mathematic studies at the Program for Evolutionary Dynamics ... Jeffrey Epstein VI Foundation , have shown that the ... elimination. These aggressive cells are the driver mutations that drive ... of what to look for when examining tumors, comes at ... can be extracted from biopsy, it,s very difficult to know ...
Breaking Biology Technology:Internationals Seaweed Fertilizer Industry 2014 Development Trend Analysis in New Research Study at DeepResearchReports.com 2Internationals Seaweed Fertilizer Industry 2014 Development Trend Analysis in New Research Study at DeepResearchReports.com 3His Majesty Willem-Alexander, King of the Netherlands, to Attend Project LIBERTY opening 2His Majesty Willem-Alexander, King of the Netherlands, to Attend Project LIBERTY opening 3The College of New Rochelle Becomes First Private College in Mid-Hudson Region to Earn START-UP NY Designation 2The College of New Rochelle Becomes First Private College in Mid-Hudson Region to Earn START-UP NY Designation 3Science Power Jeffrey Epstein and Harvard University Fund Project to Visually Stop Tumor Growth 2
... , COLLEGEVILLE, Pa., Aug. 11 Wyeth ... it received notice that the action date for the U.S. Food ... License Application (BLA) for Prevnar 13(TM), (Pneumococcal 13-valent ... 2009, to December 30, 2009. In response to an FDA ...
... , , PORTLAND, Ore., Aug. ... announce patent award approval on August 11 to Dimera Incorporated for ... known as Peripheral Vascular Disease (PVD). , , ... (Number 7572780 ) covers the period August 11, 2009 through ...
... ... sugar feedstocks, , ... (Vocus) August 11, 2009 -- BP and Martek Biosciences Corporation (Nasdaq: MATK), today announced ... microbial oils for biofuels applications. The partnership combines a broad technology platform and operational ...
Cached Biology Technology:Wyeth Provides Regulatory Update on Prevnar 13* in the United States 2Wyeth Provides Regulatory Update on Prevnar 13* in the United States 3Wyeth Provides Regulatory Update on Prevnar 13* in the United States 4Wyeth Provides Regulatory Update on Prevnar 13* in the United States 5Wyeth Provides Regulatory Update on Prevnar 13* in the United States 6Peripheral Artery Disease (PAD) Patent Granted to Dimera 2BP and Martek Biosciences Enter Joint Development Agreement to Deliver Advanced Biodiesels 2BP and Martek Biosciences Enter Joint Development Agreement to Deliver Advanced Biodiesels 3BP and Martek Biosciences Enter Joint Development Agreement to Deliver Advanced Biodiesels 4
(Date:8/22/2014)... RIVERSIDE, Calif. Thomson Reuters , a leading ... five researchers at the University of California, Riverside in ... brightest minds of our times." , To generate the ... (2002-2012) to identify researchers whose published work has had ... included among some 3,200 individuals who published the greatest ...
(Date:8/22/2014)... remember the after-effects, including pain, swelling or redness. These ... the injury. When tissue in the body is damaged, ... An inflammatory response acts as a protective mechanism to ... after injuries such as wounds and burns. However, the ... which foreign material is introduced, for example when synthetics ...
(Date:8/22/2014)... reductase (DHCR24) is a multifunctional enzyme ... and has neuroprotective and cholesterol-synthesizing activities. ... caused by amyloid β deposition. Dr. ... University in China constructed two recombinant ... DHCR24 expression specifically in neuronal cells. ...
Breaking Biology News(10 mins):5 UC Riverside scientists among world's most influential scientific minds 2Tissue regeneration using anti-inflammatory nanomolecules 2
... supermarket headlines tell us so., Inquiring Texas research minds ... tiny, sometimes obscure pest that can damage plants during ... cotton for about four weeks," said Dr. Megha Parajulee, ... feed on new plant growth, primarily the first small ...
... ago, "ultraconserved elements" were discovered in the genomes of mice, ... in length or longer -- some are over 700 base ... three species. They have been perfectly conserved since the last ... 85 million years ago. These and other highly ...
... cells could take a mix of enzyme ingredients, blend ... elaborate chemical structure such as penicillin. Researchers at UC ... of Pharmacy and Pharmaceutical Sciences and the University of ... to mimic this process outside of a cell. ...
Cached Biology News:Inquiring minds want to know about cotton fleahoppers 2Inquiring minds want to know about cotton fleahoppers 3Ultraconserved elements in the genome: Are they indispensable? 2Ultraconserved elements in the genome: Are they indispensable? 3Ultraconserved elements in the genome: Are they indispensable? 4Researchers develop simple method to create natural drug products 2
Purified anti-Fanconi anemia D2-Phosphorylated (Ser222)...
... processes up to 48 lanes, 24 bi-directional, ... can be from either slab gel or ... chemistries. The detection parameters in Explorer have ... consistency. We have built Explorer for ...
... Quality ISO 9001:2000 Certified ... All Precedures Validated, SOP's Training ... Process for All Procedures GLP Documentation Upon ... one stop shopping point for all your ...
...
Biology Products: