ELI LILLY

ELI LILLY

approved_indications FDA Approved Biologics and Pending Applications


Basaglar®

insulin glargine
NDA 205692 [505(b)(2)]

Cyramza®

ramucirumab
BL 125477

Emgality

galcanezumab-gnlm
BL 761063

Erbitux®

cetuximab
BL 125084

Forteo®

teriparatide
NDA 021318 [505(b)(2)]

Glucagon®

glucagon
NDA 20928

Lartruvo®

olaratumab
BL 761038

Portrazza®

necitumumab
BL 125547

Taltz

ixekizumab
BL 125521

Trulicity®

dulaglutide
BL 125469

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Abasaglar (insulin glargine recombinant) (Eli Lilly / Boehringer Ingelheim) (September-2014)

Biosimilars Approved In Australia

Basaglar (insulin glargine recombinant) (Eli Lilly Australia) (November-2014)

Biosimilars Approved In Japan

Insulin glargine BS (insulin glargine recombinant) (Eli Lilly / Boehringer Ingelheim) (December-2014)

approved_indications Inter Partes Review Proceedings


ERBITUXIPR2016-00458
AJOVY / EMGALITYIPR2018-01422
IPR2018-01423
IPR2018-01424
IPR2018-01425
IPR2018-01426
IPR2018-01427
IPR2018-01710
IPR2018-01711
IPR2018-01712

approved_indications U.S. Patent Litigations


ERBITUX2:13-cv-07248 (C.D. Cal.)
2:15-cv-06133 (E.D. Pa.)
4:13-cv-00919 (N.D. Cal.)
FORTEO1:16-cv-00596 (S.D. Ind.)
AJOVY / EMGALITY1:17-cv-12087 (D. Mass.)
1:18-cv-10242 (D. Mass.)
1:18-cv-12029 (D. Mass.)
ERBITUX / GENENTECH CABILLY2:13-cv-07248 (C.D. Cal.)
4:13-cv-00919 (N.D. Cal.)
LANTUS / LANTUS SOLOSTAR / BASAGLAR1:14-cv-00113 (D. Del.)
1:14-cv-00884 (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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