PFIZER

PFIZER

approved_indications FDA Approved Biologics and Pending Applications

Genotropin®

somatropin
NDA 20280

Ixifi

infliximab-qbtx
BL 761072

Nivestym

filgrastim-aafi
aBL 761080

PF-05280014

trastuzumab
PF-05280014 Approval Pending

Retacrit®

epoetin alfa-epbx
aBL 125545

approved_indications Inter Partes Review Proceedings

AVASTINIPR2016-01771
IPR2018-00373
RITUXANIPR2017-01115
IPR2017-01166
IPR2017-01167
IPR2017-01168
IPR2017-01923
IPR2017-02126
IPR2017-02127
IPR2018-00086
IPR2018-00186
IPR2018-00231
IPR2018-00285
HERCEPTIN / PF-05280014IPR2017-00731
IPR2017-00737
IPR2017-00739
IPR2017-00804
IPR2017-00805
IPR2017-01488
IPR2017-01489
IPR2017-01726
IPR2017-01727
IPR2017-02019
IPR2017-02020
IPR2017-02063
IPR2018-00016
IPR2018-00330
IPR2018-00331

approved_indications U.S. Patent Litigations

AVONEX / BETASERON / EXTAVIA / REBIF2:10-cv-02734 (D.N.J.)
2:10-cv-02760 (D.N.J.)
HERCEPTIN / PF-05280014 / GENENTECH CABILLY1:17-cv-01672 (D. Del.)
NEUPOGEN / NIVESTYM1:18-cv-01064 (D. Del.)
OPDIVO / BAVENCIO1:17-cv-01029 (D. Del.)

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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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