SANOFI

SANOFI

approved_indications FDA Approved Biologics and Pending Applications


Adlyxin®

lixisenatide
BL 208471

Admelog® / Admelog SoloStar®

insulin lispro recombinant
aBL 209196

Apidra® / Apidra SoloSTAR®

insulin glulisine recombinant
BL 021629

Elitek®

rasburicase
BL 103946

Kevzara®

sarilumab
BL 761037

Lantus® / Lantus® SoloSTAR®

insulin glargine recombinant
BL 021081

Praluent®

alirocumab
BL 125559

Sarclisa®

isatuximab-irfc
BL 761113

Soliqua® 100/33

insulin glargine; lixisenatide
BL 208673

Toujeo Solostar®

insulin glargine recombinant
aBL 206538

Zaltrap®

ziv-aflibercept
BL 125418

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Trurapi (insulin aspart) (Sanofi) (February-2021)

Biosimilars Approved In The E.U.

Admelog® (insulin lispro recombinant) (Sanofi) (July-2017)Insulin Aspart Sanofi (insulin aspart) (Sanofi) (July-2020)

Biosimilars Approved In Australia

Truvelog (insulin aspart) (Sanofi) (October-2020)

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
IPR2019-00977
IPR2019-00978
IPR2019-00979
IPR2019-00980
IPR2019-00981
IPR2019-00982
IPR2019-00987
IPR2019-01022
IPR2019-01023
IPR2019-01657
IPR2019-01658
LANTUS / LANTUS SOLOSTAR / SEMGLEEIPR2017-01526
IPR2017-01528
IPR2018-01670
IPR2018-01675
IPR2018-01676
IPR2018-01677
IPR2018-01678
IPR2018-01679
IPR2018-01680
IPR2018-01682
IPR2018-01684
IPR2018-01696
IPR2019-00122
IPR2019-01657
IPR2019-01658

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.)
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.)
LANTUS / LANTUS SOLOSTAR / SEMGLEE2:17-cv-09105 (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.)

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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