U.S. District Court Grants Summary Judgment for Axinn’s Client Zydus in FDA Case
May 27, 2015
Axinn attorneys, advocating on behalf of client Zydus Pharmaceuticals as a Defendant-Intervenor on the side of the U.S. Food and Drug Administration, won a summary judgment that affirms the FDA’s authority and practice of allowing specific label carve-outs by ANDA generic drug makers. The U.S. District Court in Maryland rejected Otsuka’s claim that the drug aripiprazole, which Otsuka markets under the name Abilify®, maintains market exclusivity from any generic use by virtue of its designation as an orphan drug for use in treating pediatric patients with Tourette’s disorder.
The price competition created by the entry of generic versions of this prescription drug into the marketplace will benefit consumers who require aripiprazole to effectively treat a myriad of other medical conditions.
To subscribe to our publications, click here.
Featured Insights
Featured Insights
CCWC 21st Annual Career Strategies Conference
Speaking Engagement
SCCE 23rd Annual Compliance & Ethics Institute
Speaking Engagement
Antitrust
HNBA/VIA Annual Convention 2025
Sponsorship
Antitrust
Key Appellate Decisions Shaping Antitrust Strategy
Webinar
Antitrust
ACI 12th Annual Summit for Women Leaders in Life Sciences Law
Speaking Engagement
Intellectual Property
National LGBTQ+ Bar Association Lavender Law Conference and Career Fair 2025
Sponsorship
National Bar Association 100th Annual Convention and Exhibits
Sponsorship
Antitrust
Axinn Attorneys Named to the 2025 Lawdragon 500 X – The Next Generation Guide
Awards & Recognitions
Keeping Pace: Updates in Cartel Enforcement
Webinar
Antitrust
Hanging in the Balance: Supreme Court Declines to Decide the Uninjured Class Member Question in Labcorp v. Davis
Axinn Viewpoints
Antitrust