Statistics at a Glance

Statistics
at a Glance

 

This figure shows PGR institution rates by technology.  Within this relatively small data set, PGR institution rates varied, with TC 1600 patent challenges being instituted at a similar rate compared to that for all PGR institutions, while Orange Book-listed drug and biologic drug patent challenges were instituted less frequently.  While the data available is still limited, we continue to monitor PGR decisions on those patents to determine whether this trend continues.

 

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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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