ROCHE (HOFFMANN-LA ROCHE)

ROCHE (HOFFMANN-LA ROCHE)

approved_indications FDA Approved Biologics and Pending Applications


Mircera®

methoxy polyethylene glycol-epoetin beta
BL 125164

Pegasys®

peginterferon alfa-2a
BL 103964

Zenapax®

daclizumab
BL 103749

approved_indications Inter Partes Review Proceedings


ENBRELIPR2015-01792
IPR2017-01916
IPR2017-02066
ACTEMRA / CT-P47IPR2022-00578
IPR2022-00579
ACTEMRA / TYENNEIPR2021-01288
IPR2021-01336
IPR2021-01542
IPR2022-00201
IPR2022-01065

approved_indications U.S. Patent Litigations


HERCEPTIN1:10-cv-00799 (D. Del.)
1:18-cv-00095 (D. Del.)
1:18-cv-01025 (D. Del.)
4:18-cv-00274 (N.D. Cal.)
ACTEMRA / TOFIDENCE1:23-cv-11573 (D. Mass.)
ENBREL / ERELZI2:16-cv-01118 (D.N.J.)
3:13-cv-02904 (N.D. Cal.)
ENBREL / ETICOVO2:19-cv-11755 (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 / DRL_RI1:23-cv-22485 (D.N.J.)
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.

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