TEVA

TEVA

approved_indications FDA Approved Biologics and Pending Applications


Ajovy®

fremanezumab-vfrm
BL 761089

AVT04

ustekinumab
AVT04 Approval Pending

Cinqair®

reslizumab
BL 761033

Granix®

tbo-filgrastim
BL 125294

Herzuma®

trastuzumab-pkrb
aBL 761091

Simlandi®

adalimumab-ryvk
aBL 761299

Teriparatide Teva

teriparatide
ANDA 208569

Truxima®

rituximab-abbs
aBL 761088

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Herzuma® (trastuzumab) (Celltrion / Teva) (September-2019)Ranopto® (ranibizumab) (Bioeq / Teva) (December-2023)Teva-teriparatide (teriparatide) (Teva) (June-2020)

Biosimilars Approved In The E.U.

Ongavia (ranibizumab) (Teva / Bioeq) (May-2022 in the United Kingdom) Ovaleap (follitropin alfa/beta) (Teva Pharma) (September-2013)Ranivisio (ranibizumab) (Teva / Bioeq) (August-2022)Tevagrastim (filgrastim) (Teva Generics) (September-2008)

Biosimilars Approved In Australia

Tevagrastim (filgrastim) (Teva Pharma Australia) (August-2011)

Biosimilars Approved In Japan

Filgrastim BS (filgrastim) (Teva Pharma Japan / Nippon Kayaku) (February-2013)

approved_indications Inter Partes Review Proceedings


AJOVY / EMGALITYIPR2018-01422
IPR2018-01423
IPR2018-01424
IPR2018-01425
IPR2018-01426
IPR2018-01427
IPR2018-01710
IPR2018-01711
IPR2018-01712
IPR2022-00738
IPR2022-00739
IPR2022-00796
HERCEPTIN / HERZUMAIPR2017-01121
IPR2017-01122
IPR2017-01139
IPR2017-01140
IPR2017-01373
IPR2017-01374
RITUXAN / TRUXIMAIPR2016-01614
IPR2016-01667
IPR2017-01093
IPR2017-01094
IPR2017-01095
IPR2017-01227
IPR2017-01229
IPR2017-01230
IPR2018-01019

approved_indications U.S. Patent Litigations


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.)
1:21-cv-10954 (D. Mass.)
GRANIX / NEUPOGEN / NEULASTA2:13-cv-04911 (D.N.J.)
HERCEPTIN / HERZUMA / GENENTECH CABILLY1:18-cv-00095 (D. Del.)
1:18-cv-01025 (D. Del.)
4:18-cv-00274 (N.D. Cal.)
RITUXAN / TRUXIMA / GENENTECH CABILLY1:18-cv-00574 (D.N.J.)
1:18-cv-11553 (D.N.J.)
4:18-cv-00276 (N.D. Cal.)

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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