REGENERON

REGENERON

approved_indications FDA Approved Biologics and Pending Applications


Arcalyst®

rilonacept
BL 125249

Dupixent®

dupilumab
BL 761055

Evkeeza®

evinacumab-dgnb
BL 761181

Eylea®

aflibercept
BL 125387

Eylea® HD

aflibercept
BL 761355

Inmazeb®

atoltivimab; odesivimab; maftivimab
BL 761169

Libtayo®

cemiplimab-rwlc
BL 761097

Veopoz

pozelimab-bbfg
BL 761339

approved_indications Inter Partes Review Proceedings


DUPIXENTIPR2017-01129
IPR2017-01879
IPR2017-01884
EYLEAIPR2020-01317
IPR2020-01318
IPR2020-01320
IPR2021-00402
IPR2021-00816
IPR2021-00880
IPR2021-00881
IPR2022-00257
IPR2022-00258
IPR2022-00298
IPR2022-00301
IPR2022-01225
IPR2022-01226
IPR2022-01524
IPR2023-00099
IPR2023-00442
IPR2023-00462
IPR2023-00532
IPR2023-00533
IPR2023-00566
IPR2023-00620
IPR2023-00739
IPR2023-00884
IPR2023-01312
IPR2024-00201
IPR2024-00260
IPR2024-00298
PGR2021-00035
PGR2021-00117
GENENTECH CABILLYIPR2015-01624
EYLEA / CT-P42IPR2022-00257
IPR2022-00258
IPR2023-00462
IPR2023-00532
IPR2023-00533
IPR2023-00620
IPR2024-00260
PGR2021-00117
EYLEA / LUCENTISIPR2020-01317
IPR2020-01318
IPR2020-01320
IPR2021-00816
EYLEA / OPUVIZIPR2023-00442
IPR2023-00566
IPR2023-00739
IPR2023-00884
IPR2023-01312
EYLEA / YESAFILIIPR2021-00880
IPR2021-00881
IPR2022-01225
IPR2022-01226
IPR2023-00099
IPR2024-00201
IPR2024-00298

approved_indications U.S. Patent Litigations


DUPIXENT1:17-cv-10465 (D. Mass.)
2:17-cv-02613 (C.D. Cal.)
EYLEA1:18-cv-02434 (S.D.N.Y.)
1:20-cv-00690 (N.D.N.Y.)
1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:23-cv-00089 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:23-cv-00094 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:24-cv-00039 (N.D.W. Va.) (transferred from 1:24-cv-00264 (C.D. Cal.)) / MDL 1:24-md-03103 (N.D.W. Va.)
1:24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:24-cv-00085 (N.D.W. Va.) (transferred from 2:24-cv-08760 (D.N.J.)) / MDL 1:24-md-03103 (N.D.W. Va.)
ZALTRAP1:18-cv-02434 (S.D.N.Y.)
7:11-cv-09463 (S.D.N.Y.)
EYLEA / AHZANTIVE1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
EYLEA / CT-P421:23-cv-00089 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
EYLEA / ENZEEVU1:24-cv-00085 (N.D.W. Va.) (transferred from 2:24-cv-08760 (D.N.J.)) / MDL 1:24-md-03103 (N.D.W. Va.)
EYLEA / LUCENTIS / ZALTRAP1:18-cv-02434 (S.D.N.Y.)
EYLEA / OPUVIZ1:23-cv-00094 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
EYLEA / PAVBLU1:24-cv-00039 (N.D.W. Va.) (transferred from 1:24-cv-00264 (C.D. Cal.)) / MDL 1:24-md-03103 (N.D.W. Va.)
EYLEA / YESAFILI1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
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.

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