Statistics at a Glance

Statistics
at a Glance

 

This figure shows the bases for PGR denials over time.  FY 2025 estimates are calculated based on statistics from October 1, 2024 through December 31, 2024.

The PTAB has increasingly denied PGR (and IPR) institutions for procedural reasons.  In 2021, procedural denials were the most frequent reason for PGR institution denials, but this has dropped in FY 2022 – 2024.

 

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    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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