Navigation Links
Jazz Pharmaceuticals Announces Paragraph IV ANDA Filing for Xyrem
Date:10/5/2010

PALO ALTO, Calif., Oct. 5 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the website of the US Food and Drug Administration indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Xyrem® (sodium oxybate oral solution) 500 mg/ml was submitted on July 8, 2010.  Jazz Pharmaceuticals has not received a Paragraph IV certification with respect to this filing.

Jazz Pharmaceuticals intends to vigorously enforce its intellectual property rights.  Xyrem is protected by seven patents covering its formulation and the company's distribution system for the product, including five patents listed in the FDA's Approved Drug Products List (the Orange Book).  

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see www.JazzPharmaceuticals.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, Jazz Pharmaceuticals' intent to vigorously enforce its intellectual property rights.  These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties.  Jazz Pharmaceuticals' actual results could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of the company to protect its intellectual property and defend its patents, the possible introduction of generic products, the dependence of the company on sale
'/>"/>

SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Ground Zero Pharmaceuticals Announces Expansion of Global Consulting in Somatic Cell Therapies
2. OncoGenex Pharmaceuticals to Present at the 9th Annual BIO Investor Forum
3. Access Pharmaceuticals Furthers Progress on Its Cobalamin-mediated Targeted Drug Delivery Platform for siRNA
4. Syndax Pharmaceuticals to Present at BIO Investor Forum
5. ISTA Pharmaceuticals Highlights Clinical Data from REMURAâ„¢ Phase 2 Study Presented at the 6th International Conference on the Tear Film & Ocular Surface
6. Jiangbo Pharmaceuticals Announces Conference Call to Discuss Results for Fourth Quarter Fiscal 2010
7. OncoGenex Pharmaceuticals, Inc. - Journal of Clinical Oncology Publishes Data from Randomized Phase 2 Custirsen Trial
8. TOPICA Pharmaceuticals Announces Sublicensing Agreement for Tinea Indication
9. Keryx Biopharmaceuticals to Present at the UBS 2010 Global Life Sciences Conference
10. Optimer Pharmaceuticals Phase 3 Clinical Trials show Fidaxomicin is Superior to Vancomycin in Treatment of Recurrent Clostridium difficile Infection (CDI); Data Presented at ICAAC
11. Edimer Pharmaceuticals and CMC Biologics Announce Agreement to Manufacture EDI200 Recombinant Protein
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Nobel laureate Herbert Kroemer famously observed, referring to ... junctures where layers of different materials meet. In ... layers of metal oxides are becoming increasingly prominent, ... high-temperature superconductors, ferroelectrics and multiferroics. Realizing the vast ...
(Date:1/15/2014)... The Pittcon Organizing Committee is pleased to ... Tech , an e-Journal and producer of Food ... second year for the co-location of Food Labs Conference to ... that the registration fee to attend the two-day Food Lab ...
(Date:1/15/2014)... 2014 Look inside the new Preferred ... the lab, from fluid handling to instruments to supplies. ... when you order. , Preferred Solutions features a ... the L/S® model for precise flow control and dispensing ...
(Date:1/15/2014)... and SAN JOSE, California , January 15, ... developing antibody-drug conjugates for cancer, today announced the appointment of ... Dr Reynolds has over 20 years, development experience gained in ... Seattle Genetics. "I am delighted to welcome Tom ...
Breaking Biology Technology:A deeper look at interfaces 2Pittcon Announces Second Year Partnership With Food Safety Tech 2Pittcon Announces Second Year Partnership With Food Safety Tech 3Cole-Parmer Begins 2014 with the Release of Preferred Solutions 2Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 2Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 3
... announced on Sunday they have successfully created embryonic stem ... affect some of the ethical debate over their use ... Wisconsin-Madison professor cautions that the breakthrough has limited repercussions. ... of the research journal Science, researchers Chad ...
... made significant progress in improving business conditions in the ... restrictions if the state is to better capitalize on ... , ,"Today it is easier to legally gamble your ... emerging, growth Wisconsin companies," said Terry Grosenheider, a US ...
... is the first in a new UW E-Business Consortium ... of Wisconsin E-Business Consortium in 2002. , ,People ... appliance design. The brand those valued consumers turn to ... built-in refrigeration units can be seamlessly integrated to match ...
Cached Biology Technology:Harvard advance improves stem cell research; not a medical revolution 2Regulations still stymie business investment in high-growth companies 2Regulations still stymie business investment in high-growth companies 3Regulations still stymie business investment in high-growth companies 4How Sub-Zero Freezer Co. uses technology to revolutionize customer service 2How Sub-Zero Freezer Co. uses technology to revolutionize customer service 3
(Date:7/10/2014)... or GOES-West satellite spotted smoke over the U.S. ... Northwestern Territories. , At 1200 UTC (8 a.m. ... image of the brownish-colored haze created by forest ... the way into South Dakota. This image was ... Goddard Space Flight Center, Greenbelt, Md. , ...
(Date:7/10/2014)... organization funding cutting-edge, innovative research on Alzheimer,s disease ... degeneration, today announced the recipients of new research ... U.S. states, the District of Columbia, and five ... With these latest grants, BrightFocus has now provided ... 2014. , The research projects funded this year ...
(Date:7/10/2014)... currents in the Straits of Mackinac reverse direction every ... the channel would quickly contaminate shorelines miles away in ... University of Michigan study commissioned by the National Wildlife ... and accompanying animations, oil from a hypothetical pipeline break ... and Bois Blanc Island after two days. All three ...
Breaking Biology News(10 mins):BrightFocus Foundation announces 55 new grantees in Alzheimer's and vision research 2BrightFocus Foundation announces 55 new grantees in Alzheimer's and vision research 3Straits of Mackinac 'worst possible place' for a Great Lakes oil spill 2Straits of Mackinac 'worst possible place' for a Great Lakes oil spill 3
... NEW YORK (Jan. 20, 2010) -- In a significant ... variety of diseases, a team of scientists at Weill ... described a novel mechanism for turning human embryonic and ... are critical to the formation of blood vessels. Endothelial ...
... seed money from the National Science Foundation (NSF), bioengineers ... are ramping up efforts to characterize the thousands of ... that eventually, researchers can mix and match these "DNA ... or chemicals. Today, a single designer microbe can ...
... available in French . , Chicken sold in ... risk of urinary tract infections (UTI), McGill researcher Amee Manges ... and 2007, in collaboration with the Public Health Agency of ... that E. coli ( Escherichia coli ) bacteria ...
Cached Biology News:New way to generate abundant functional blood vessel cells from human stem cells discovered 2New way to generate abundant functional blood vessel cells from human stem cells discovered 3New way to generate abundant functional blood vessel cells from human stem cells discovered 4NSF grant to launch world's first open-source genetic parts production facility 2NSF grant to launch world's first open-source genetic parts production facility 3NSF grant to launch world's first open-source genetic parts production facility 4Retail meat linked to urinary tract infections: Strong new evidence 2
... System creates isogenic cell lines all ... the protein of interest. This homogeneous ... (click link below). In this experiment ... (CAT) was subcloned into pcDNA5/FRT and ...
Fast, sensitive quantitation of total MEK 1/2 concentration....
... for 50 L samples. Operating head automatically rises at the end of determination; triple-point calibration verification; refrigerator ... ... ... ...
SHEEP ANTI ESCHERICHIA COLI...
Biology Products: