Statistics at a Glance

Statistics
at a Glance

 

This figure shows the number of PGR and IPR petitions filed since their inception in 2012 through June 30, 2024.  2024 estimates are calculated based on statistics from January 1, 2024 through June 30, 2024.  For our analysis, we reviewed PGR filings for all patent technologies (teal line) as well as the subsets of PGRs filed on Orange Book-listed patents (orange line), CDER-listed biologic drug patents (“Biologics”) (purple line), and TC 1600 patents (blue line).

 

BiologicsHQ and materials published on BiologicsHQ are published for informational purposes only.  Neither the information nor any opinion expressed on BiologicsHQ constitute legal advice, create an attorney-client relationship, or constitute a solicitation for business.

 

    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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