GENENTECH

GENENTECH

approved_indications FDA Approved Biologics and Pending Applications


Actemra®

tocilizumab
BL 125276 [BL 125472]

Activase® / Cathflo® Activase®

alteplase
BL 103172

Avastin®

bevacizumab
BL 125085

Gazyva®

obinutuzumab
BL 125486

Genentech Cabilly


Hemlibra®

emicizumab-kxwh
BL 761083

Herceptin®

trastuzumab
BL 103792

Kadcyla®

ado-trastuzumab emtansine
BL 125427

Lucentis®

ranibizumab
BL 125156

Ocrevus

ocrelizumab
BL 761053

Perjeta®

pertuzumab
BL 125409

Pulmozyme®

dornase alfa
BL 103532

Rituxan Hycela

rituximab; hyaluronidase
BL 761064

Rituxan®

rituximab
BL 103705 [BL 103737]

Tecentriq®

atezolizumab
BL 761034

TNKase®

tenecteplase
BL 103909

Xolair®

omalizumab
BL 103976

approved_indications Inter Partes Review Proceedings


AVASTINIPR2016-01771
IPR2018-00373
GENENTECH CABILLYIPR2015-01624
IPR2016-00383
IPR2016-00460
IPR2016-00710
IPR2016-01373
IPR2017-00047
HERCEPTINIPR2016-01693
IPR2016-01694
IPR2016-01837
IPR2017-00731
IPR2017-00737
IPR2017-00739
IPR2017-00804
IPR2017-00805
IPR2017-00959
IPR2017-01121
IPR2017-01122
IPR2017-01139
IPR2017-01140
IPR2017-01373
IPR2017-01374
IPR2017-01488
IPR2017-01489
IPR2017-01726
IPR2017-01727
IPR2017-01958
IPR2017-01959
IPR2017-01960
IPR2017-02019
IPR2017-02020
IPR2017-02063
IPR2017-02139
IPR2017-02140
IPR2018-00016
IPR2018-00192
IPR2018-00330
IPR2018-00331
KADCYLAIPR2014-00676
IPR2014-00842
RITUXANIPR2015-00415
IPR2015-00417
IPR2015-01733
IPR2015-01744
IPR2016-01614
IPR2016-01667
IPR2017-01115
IPR2017-01227
IPR2017-01229
IPR2017-01230
IPR2017-01923
IPR2017-02036
IPR2017-02042
IPR2017-02126
IPR2017-02127
IPR2018-01019
HERCEPTIN / HERZUMAIPR2017-00959
IPR2017-01121
IPR2017-01122
IPR2017-01139
IPR2017-01140
IPR2017-01373
IPR2017-01374
HERCEPTIN / OGIVRIIPR2016-01693
IPR2016-01694
HERCEPTIN / SB3IPR2017-01958
IPR2017-01959
IPR2017-01960
IPR2017-02139
IPR2017-02140
IPR2018-00192
RITUXAN / RIXATHONIPR2017-02036
IPR2017-02042
RITUXAN / TRUXIMAIPR2015-01733
IPR2015-01744
IPR2016-01614
IPR2016-01667
IPR2017-01227
IPR2017-01229
IPR2017-01230
IPR2018-01019

approved_indications U.S. Patent Litigations


ELITEK2:15-cv-01143 (W.D. Wash.)
HEMLIBRA1:17-cv-00509 (D. Del.)
HERCEPTIN1:10-cv-00799 (D. Del.)
1:17-cv-01672 (D. Del.)
1:18-cv-00095 (D. Del.)
1:18-cv-00924 (D. Del.)
1:18-cv-01025 (D. Del.)
1:18-cv-01363 (D. Del.)
3:08-cv-04909 (N.D. Cal.)
3:09-cv-04919 (N.D. Cal.)
4:18-cv-00274 (N.D. Cal.)
5:10-cv-02037 (C.D. Cal.)
5:10-cv-04255 (C.D. Cal.)
KADCYLA1:14-cv-00287 (N.D. Ga.)
5:15-cv-01238 (N.D. Cal.)
ZALTRAP7:11-cv-09463 (S.D.N.Y.)
ACTIVASE / CATHFLO ACTIVASE / AVASTIN / HERCEPTIN / PULMOZYME / RITUXAN / TNKASE / XOLAIR3:08-cv-04909 (N.D. Cal.)
3:09-cv-04919 (N.D. Cal.)
AVASTIN / MVASI1:17-cv-00165 (D. Del.)
1:17-cv-01407 (D. Del.)
1:17-cv-01471 (D. Del.)
2:17-cv-07349 (C.D. Cal.)
AVASTIN / MVASI / GENENTECH CABILLY1:17-cv-01407 (D. Del.)
1:17-cv-01471 (D. Del.)
2:17-cv-07349 (C.D. Cal.)
BENLYSTA / GENENTECH CABILLY1:11-cv-00082 (D. Del.)
1:11-cv-00328 (D. Del.)
2:11-cv-03065 (C.D. Cal.)
2:11-cv-06519 (C.D. Cal.)
2:11-cv-06594 (C.D. Cal.)
CAMPATH / LEMTRADA / GENENTECH CABILLY2:15-cv-09991 (C.D. Cal.)
ERBITUX / GENENTECH CABILLY2:13-cv-05400 (N.D. Cal.)
2:13-cv-07248 (C.D. Cal.)
3:13-cv-02045 (N.D. Cal.)
4:13-cv-00919 (N.D. Cal.)
ERBITUX / GENENTECH CABILLY / YERVOY2:13-cv-05400 (N.D. Cal.)
3:13-cv-02045 (N.D. Cal.)
HERCEPTIN / ABP 980 / GENENTECH CABILLY1:18-cv-00924 (D. Del.)
HERCEPTIN / HERZUMA / GENENTECH CABILLY1:18-cv-00095 (D. Del.)
1:18-cv-01025 (D. Del.)
4:18-cv-00274 (N.D. Cal.)
HERCEPTIN / PF-05280014 / GENENTECH CABILLY1:17-cv-01672 (D. Del.)
HERCEPTIN / SB3 / GENENTECH CABILLY1:18-cv-01363 (D. Del.)
OPDIVO / TECENTRIQ1:17-cv-01027 (D. Del.)
PRALUENT / GENENTECH CABILLY2:15-cv-05685 (C.D. Cal.)
REOPRO / GENENTECH CABILLY2:08-cv-03573 (C.D. Cal.)
RITUXAN / RIXATHON / GENENTECH CABILLY1:17-cv-13507 (D.N.J.)
RITUXAN / TRUXIMA / GENENTECH CABILLY1:18-cv-00574 (D.N.J.)
1:18-cv-11553 (D.N.J.)
4:18-cv-00276 (N.D. Cal.)

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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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