REGENERON

REGENERON

approved_indications FDA Approved Biologics and Pending Applications

Arcalyst®

rilonacept
BL 125249

Dupixent®

dupilumab
BL 761055

Eylea®

aflibercept
BL 125387

Libtayo®

cemiplimab-rwlc
BL 761097

approved_indications Inter Partes Review Proceedings

DUPIXENTIPR2017-01129
IPR2017-01879
IPR2017-01884
GENENTECH CABILLYIPR2015-01624

approved_indications U.S. Patent Litigations

DUPIXENT1:17-cv-10465 (D. Mass.)
2:17-cv-02613 (C.D. Cal.)
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.)
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.)

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – February 2019 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. March 6, 2019
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – September 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. October 6, 2018

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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