Our latest Hatch-Waxman report, Analyzing Hatch-Waxman Litigation Trends: 2025 in Review, delivers a data-driven examination of ANDA litigation, grounded in our systematic tracking of Paragraph IV challenges and corresponding Orange Book products. This year’s review—covering 320 new ANDA cases across 124 distinct product groups—highlights evolving venue dynamics, judicial exposure to recurring technical issues, and the portfolio strategies that shaped Hatch-Waxman litigation in 2025.
To ensure analytical precision beyond automated database classifications, we manually reviewed each pharmaceutical-related complaint, identifying actions initiated by both NDA holders and ANDA filers. We evaluated these cases for overall volume and substantive litigation patterns, providing practical insight for stakeholders navigating complex Hatch-Waxman disputes.
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
Enter your information to receive a download link to the full report, and stay tuned for future installments in this series.
