TEVA

TEVA

approved_indications FDA Approved Biologics and Pending Applications


Ajovy

fremanezumab-vfrm
BL 761089

Cinqair®

reslizumab
BL 761033

Granix®

tbo-filgrastim
BL 125294

Herzuma®

trastuzumab
Herzuma® Approval Pending

Truxima®

rituximab-abbs
aBL 761088

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Ovaleap (follitropin alfa/beta) (Teva Pharma) (September-2013)Tevagrastim (filgrastim) (Teva Generics) (September-2008)

Biosimilars Approved In Australia

Tevagrastim (filgrastim) (Aspen Pharmacare 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
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.)
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.)

related articles Related News Articles


Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) April M. Breyer Menon; Corinne E. Atton; Joyce L. Nadipuram; Robert S. Schwartz, Ph.D. November 30, 2018
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 – September 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. October 6, 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 – April 2018 April M. Breyer Menon; Corinne E. Atton; Joseph K. Yarsky; Robert S. Schwartz, Ph.D. May 3, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – December 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. January 8, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 26, 2017

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

captcha