WIT Legal Releases 2nd Annual Report on Trends in Hatch-Waxman Litigation

The new report examines Abbreviated New Drug Application (ANDA) cases and the Orange Book-listed products at issue throughout 2024.

NEW YORK, Feb. 3, 2025 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released their annual report evaluating Hatch-Waxman litigation. The report, 2024 in Review: Analyzing Hatch-Waxman Litigation Trends, provides a comprehensive look at 2024's ANDA cases, including the drugs at issue, the key players involved in disputes, and the judges overseeing cases.

"With these annual reports, our goal remains to deliver the most in-depth analysis of true ANDA litigation in the industry," said Michael Connelly, WIT President. "By thoroughly examining the complaints filed over the past year, we can identify trends and anticipate the types of pharmaceutical experts that will be most in demand and impactful for our clients."

Some key findings in the report include:

• ANDA cases peaked at 304 in 2024, up from 239 in 2023
• Multrys/Tralement and Caplyta generated the most activity, contrasting 2023's focus on Xarelto and Orilissa/Oriahnn litigation
• Venue patterns shifted markedly, with New Jersey experiencing a 100% increase in filings (from 85 to 170 cases) while Delaware saw an 18% decrease (142 to 116 cases)
• Drugs treating endocrinological conditions were the most frequently litigated among top Orange Book-listed products, shifting from last year's focus on rare diseases and conditions
• While Judges Andrews and Williams dominated 2023's ANDA docket, 2024 saw Judges Martinotti and Shipp overtake their caseload

Additionally, the report goes beyond the specific companies involved to provide insight into the corporate families driving ANDA litigation to highlight potential market dynamics and litigation trends. In our findings, American Regent emerged as the top New Drug Application (NDA) Holder represented in 43 cases, while Aurobindo Pharma was the top ANDA filer represented in 25 cases.

"We are dedicated to supporting parties involved in ANDA litigation," said WIT's Hatch-Waxman Chair Michael Crowe. "Our team has worked with hundreds of testifying experts in cases before district courts and the U.S. Patent and Trademark Office (USPTO). Attorneys representing life sciences clients count on us to provide the most qualified and experienced experts for their pharmaceutical disputes."

To learn more about WIT's Hatch-Waxman Practice or to download the report, visit https://www.witlegal.com/hatch-waxman-litigation/.

About WIT Legal, LLC.

WIT is the leading agency representing testifying experts in legal disputes involving advanced technologies and life sciences. We focus on industries with increased risk of litigation and build expert teams comprised of world-class academics, industry executives, and former government regulators. Partnering with WIT assures that you engage with testifying experts who have been selected for their knowledge, experience, and ability to communicate effectively.

For more information about WIT, visit WITlegal.com and follow us at @WITexperts.

Media Inquiries:

Cindy Siegel
Vice President of Marketing, WIT Legal, LLC
[email protected]

SOURCE WIT Legal, LLC