Biosimilar-Related IPR Outcomes by Petition and Patent

Biosimilar-Related IPR Outcomes by Petition and Patent

*Biosimilar-related IPR outcomes by petition and by patent.  IPRs that are still pending are not included.  Settled / Terminated includes IPRs that were settled or terminated at the Petitioner’s request prior to a final written decision, and include IPRs terminated...
PGR Filings over Time by Technology

PGR Filings over Time by Technology

  2024 estimates are calculated based on statistics from January 1, 2024 through June 30, 2024.     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...

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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