Published: March 19, 2024
WIT Legal, LLC

Our inaugural Hatch-Waxman report, 2023 in Review: Analyzing Hatch-Waxman Litigation Trends, provides a comprehensive look at 2023’s activities and trends in Hatch-Waxman litigation.

In creating this report, WIT closely monitored declaratory judgment actions directly stemming from the Hatch-Waxman generic drug approval process, specifically those involving pending ANDAs. To ensure precision beyond automated database tags, WIT’s Hatch-Watchman Practice team 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. These will be released bi-monthly and begin in May. 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.

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