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Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo® (pegfilgrastim-bmez) / Nyvepria®(pegfilgrastim-apgf) / Fylnetra™ (pegfilgrastim-apgf) / Stimufend® (pegfilgrastim-fpgk)

by April Breyer Menon; Damineh Morsali, Ph.D. ; Robert S. Schwartz, Ph.D.
July 31, 2025

 

 

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*Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs.  Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs are counted more than once.  Within each litigation a claim is counted only once.  Within each IPR, claims are counted only once, whether they are challenged under § 102, § 103, or both.  Claims in litigations are determined based on claims alleged to be infringed or invalid in Complaints.

 

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    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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