SANOFI

SANOFI

approved_indications FDA Approved Biologics and Pending Applications


Elitek®

rasburicase
BL 103946

Kevzara®

sarilumab
BL 761037

Lantus® / Lantus® SoloSTAR®

insulin glargine recombinant
NDA 021081

Praluent®

alirocumab
BL 125559

Toujeo Solostar®

insulin glargine recombinant
NDA 206538

Zaltrap®

ziv-aflibercept
BL 125418

approved_indications Inter Partes Review Proceedings


DUPIXENTIPR2017-01129
IPR2017-01879
IPR2017-01884
GENENTECH CABILLYIPR2015-01624
IPR2016-00383
IPR2016-00460
LANTUS / LANTUS SOLOSTARIPR2017-01526
IPR2017-01528
IPR2018-01670
IPR2018-01675
IPR2018-01676
IPR2018-01677
IPR2018-01678
IPR2018-01679
IPR2018-01680
IPR2018-01682
IPR2018-01684
IPR2018-01696
IPR2019-00122

approved_indications U.S. Patent Litigations


DUPIXENT1:17-cv-10465 (D. Mass.)
2:17-cv-02613 (C.D. Cal.)
ELITEK2:15-cv-01143 (W.D. Wash.)
LANTUS / LANTUS SOLOSTAR1:14-cv-00113 (D. Del.)
1:14-cv-00884 (D. Del.)
1:16-cv-00812 (D. Del.)
2:17-cv-05914 (D.N.J.)
2:17-cv-09105 (D.N.J.)
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.)
LANTUS / LANTUS SOLOSTAR / BASAGLAR1:14-cv-00113 (D. Del.)
1:14-cv-00884 (D. Del.)
LANTUS / LANTUS SOLOSTAR / LUSDUNA NEXVUE1:16-cv-00812 (D. Del.)
2:17-cv-05914 (D.N.J.)
PRALUENT / GENENTECH CABILLY2:15-cv-05685 (C.D. Cal.)
PRALUENT / REPATHA1:14-cv-01317 (D. Del.)
1:14-cv-01349 (D. Del.)
1:14-cv-01393 (D. Del.)
1:14-cv-01414 (D. Del.)

related articles Related News Articles


Venable Fitzpatrick’s BiologicsHQ Monthly Injection – October 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. November 12, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. August 3, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – June 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 6, 2018

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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