Statistics at a Glance

Statistics
at a Glance

 

Biosimilar-Related IPR Petitions include IPR petitions relating to biosimilar/follow-on products.  IPR petitions relating to disputes between reference product sponsors, or non-practicing entities/universities and reference product sponsors are not included.  IPR petitions relating to manufacturing patents that may be relevant to multiple products (for example, U.S. Patent No. 6,331,415 (a “Cabilly” patent)) also are not included.  Outcomes listed are the initial decisions by the PTAB and do not include decisions on appeal.

 

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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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