REGENERON

REGENERON

approved_indications FDA Approved Biologics and Pending Applications

Arcalyst®

rilonacept
BL 125249

Dupixent®

dupilumab
BL 761055

Eylea®

aflibercept
BL 125387

Inmazeb

atoltivimab; odesivimab; maftivimab
BL 761169

Libtayo®

cemiplimab-rwlc
BL 761097

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
PGR2021-00035
PGR2021-00117
GENENTECH CABILLYIPR2015-01624
EYLEA / LUCENTISIPR2020-01317
IPR2020-01318
IPR2020-01320
IPR2021-00816
EYLEA / M710IPR2021-00880
IPR2021-00881
IPR2022-01225
IPR2022-01226
IPR2023-00099

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.)
ZALTRAP1:18-cv-02434 (S.D.N.Y.)
7:11-cv-09463 (S.D.N.Y.)
EYLEA / LUCENTIS / ZALTRAP1:18-cv-02434 (S.D.N.Y.)
EYLEA / M7101:22-cv-00061 (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 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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