|
|
|
|
|
|
|
Free Newsletters
Archive
My Subscriptions
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers
Regional News
US & Canada
Biotech Bay
Biotech Beach
Genetown
Pharm Country
BioCapital
BioMidwest
Bio NC
BioForest
Southern Pharm
BioCanada East
US Device
Europe
Asia
Market Summary
News
IPOs
Company Profiles
Companies
Events
Research Store
Biotech Events
Post an Event
Real Estate
Business Opportunities
|
|
|
|
|
News | News By Subject | News by Disease |
News By Date | Search News
|
|
|
IMPAX Laboratories, Inc. (IPXL) and ThoRx Laboratories Confirm Patent Challenge Relating to Generic OPANA® ER 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg
11/16/2012 9:18:09 AM
HAYWARD, Calif.--(BUSINESS WIRE)--Impax Laboratories, Inc. (NASDAQ: IPXL) and its wholly owned subsidiary, ThoRx Laboratories, Inc., today confirm that they have initiated a challenge of the patents listed in the Orange Book in connection with Opana® ER (oxymorphone hydrochloride extended-release tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg). ThoRx filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Opana® ER with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from FDA that ThoRx’s ANDA had been accepted for filing, ThoRx notified the New Drug Application holder and patent owner of its paragraph IV certification. On November 14, 2012, Endo Pharmaceuticals Inc. and Grunenthal GMBH filed suit for patent infringement against ThoRx Laboratories, Inc. and Impax Laboratories, Inc. in the United States District Court for the Southern District of New York. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
|
|
|
|
|
|
|
|
|
|
|