Our latest Hatch-Waxman report, 2024 in Review: Analyzing Hatch-Waxman Litigation Trends, provides a data-driven analysis of ANDA litigation, leveraging our systematic tracking of Paragraph IV challenges and corresponding Orange Book products. This in-depth case review—covering 304 new ANDA cases across 118 distinct product groups—uncovers key shifts in venue dynamics, judicial assignments, and patent portfolio strategies that defined Hatch-Waxman litigation in 2024.
To ensure precision beyond automated database tags, we manually reviewed each pharmaceutical-related complaint, identifying cases initiated by NDA holders and ANDA filers. We analyzed these cases for both volume and substantive trends, offering insights tailored to the needs of our clients engaged in Hatch-Waxman litigation.
This report examines the key insights from that process that we think will be of interest, highlighting:
- Top ANDA and NDA filers
- Cases by Orange Book-listed ingredients and product groupings
- Unique cases by jurisdiction
- Most active judges
- Highly litigated drugs
- And more
In subsequent reports, we will focus on the most active judges overseeing Hatch-Waxman Act litigation, highlighting their backgrounds and relevant litigation statistics. Subscribe to stay up-to-date on our latest insights.
Enter your information to receive a download link to the full report, and stay tuned for future installments in this series.
