PGR Filings over Time by Technology

PGR Filings over Time by Technology

  2022 estimates are calculated based on statistics from January 1, 2022 through September 30, 2022. BiologicsHQ and materials published on BiologicsHQ are published for informational purposes only.  Neither the information nor any opinion expressed on...
PGR Final Written Decision Outcomes – TC 1600

PGR Final Written Decision Outcomes – TC 1600

  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...
PGR and IPR Filings Over Time

PGR and IPR Filings Over Time

  This figure shows the number of PGR and IPR petitions filed since their inception in 2012 through March 31, 2022.  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...
PGR Institution Rates by Technology

PGR Institution Rates by Technology

  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 (49%, n=37 of 75 and 48%,...

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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