BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Horizon Pharma, Inc. (HZNP) Files Patent Infringement Lawsuit Against Watson Laboratories, Inc. (WPI) - Florida for Filing an ANDA Against RAYOS®


8/28/2013 10:06:11 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

DEERFIELD, IL--(Marketwired - August 27, 2013) - Horizon Pharma, Inc. (NASDAQ: HZNP) today announced it, along with SkyePharma from whom it has licensed certain RAYOS® intellectual property, has filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Watson Laboratories, Inc. - Florida and certain related companies ("WLF") and related to an Abbreviated New Drug Application ("ANDA") that WLF filed with the U.S. Food and Drug Administration ("FDA") to market generic versions of RAYOS® containing 1 mg, 2 mg and 5 mg of prednisone.

The lawsuit claims infringement of U.S. Patent Nos. 6,488,960, 6,677,326, 8,168,218, 8,309,124 and 8,394,407 that are listed in the FDA's Orange Book with the latest expiration January 7, 2028. Horizon received a Paragraph IV Patent Certification from WLF on July 15, 2013, advising that WLF had filed an ANDA with the FDA for a generic version of RAYOS®. WLF alleged that its generic versions of RAYOS® would not infringe the subject U.S. patents or the patents are invalid or unenforceable. WLF has not advised Horizon as to the timing or status of the FDA's review of its filing, or whether it has complied with FDA requirements for proving bioequivalence. The defendants in the lawsuit are Watson Laboratories, Inc. - Florida, Actavis Pharma, Inc., Andrx Corp., and Actavis, Inc.

Horizon commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving WLF's ANDA for 30 months or until a district court decision that is adverse to the subject patents, whichever may occur earlier.

About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit www.horizonpharma.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding whether the FDA is prevented from approving WLF's ANDA filing until a future time. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, whether Horizon would be successful in the patent infringement litigation. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release, and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.


Contacts
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
Email Contact

Investors
Kathy Galante
Burns McClellan, Inc.
212-213-0006
Email Contact



Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES