Axinn Protects Client Endo Pharmaceuticals Inc.’s Approval for Generic Valcyte®
March 11, 2015
Axinn, on behalf of client Endo Pharmaceuticals Inc., successfully defended the U.S. Food and Drug Administration’s final approval of Endo’s generic Valcyte® by securing summary judgment in favor of Endo and FDA. Plaintiff Ranbaxy Laboratories, Ltd. had sought an order reversing FDA’s approval of Endo’s generic Valcyte® product after FDA recently decided to revoke tentative approval of Ranbaxy’s generic Valcyte® ANDA and determined that Ranbaxy had forfeited its generic marketing exclusivity rights. Judge Beryl Howell of the United Stated District Court for the District of Columbia determined that FDA had acted within its authority.
Related People
To subscribe to our publications, click here.
Featured Insights
Featured Insights
American Bar Association 2025 Asia-Pacific Conference
Speaking Engagement
Antitrust
NBA Commercial Law Section 38th Annual Corporate Counsel Conference
Sponsorship
Antitrust
GCR Live: Law Leaders Global 2025
Speaking Engagement
Antitrust
The 32nd Annual Marketing Partner Forum
Event
SABA North America Corporate Counsel Retreat 2025
Sponsorship
Antitrust
Axinn Antitrust Insight: FTC Announces Revised HSR Thresholds for 2025
Client Alerts
Antitrust
Four Axinn Thought Leadership Pieces Nominated for the Antitrust Writing Awards
Awards & Recognitions
Antitrust
Merger Remedies Back in Vogue Under Trump
Media Mentions
Antitrust
Three Takeaways from the Initial Determination at the ITC Regarding Standard Essential Patents in the 1380 Investigation
Axinn Viewpoints
Intellectual Property
A POSA’s Motivation Is Not Required To Be the Same as the Inventor’s in Evaluating Obviousness
Axinn Viewpoints
Intellectual Property
