NOVARTIS

NOVARTIS

approved_indications FDA Approved Biologics and Pending Applications


Adakveo®

crizanlizumab-tmca
BL 761128

Arzerra® / Kesimpta®

ofatumumab
BL 125326

Beovu®

brolucizumab-dbll
BL 761125

Cosentyx®

secukinumab
BL 125504 [BL 761349]

Extavia®

interferon beta-1b
BL 125290

Ilaris®

canakinumab
BL 125319

Kymriah®

tisagenlecleucel
BL 125646

Simulect®

basiliximab
BL 103764

Zolgensma®

onasemnogene abeparvovec-xioi
BL 125694

approved_indications Inter Partes Review Proceedings


KYMRIAHIPR2022-00852
IPR2022-00853
IPR2022-00855
ZOLGENSMAIPR2023-00608
IPR2023-00609
IPR2023-01044
IPR2023-01045
EYLEA / LUCENTISIPR2020-01317
IPR2020-01318
IPR2020-01320
IPR2021-00816

approved_indications U.S. Patent Litigations


EYLEA1:18-cv-02434 (S.D.N.Y.)
1:20-cv-00690 (N.D.N.Y.)
FORTICAL1:02-cv-08917 (S.D.N.Y.)
KYMRIAH2:13-cv-01502 (E.D. Pa.)
ZOLGENSMA1:21-cv-01736 (D. Del.)
1:23-cv-00554 (D. Del.)
AVONEX / BETASERON / EXTAVIA / REBIF2:10-cv-02734 (D.N.J.)
2:10-cv-02760 (D.N.J.)
EYLEA / LUCENTIS / ZALTRAP1:18-cv-02434 (S.D.N.Y.)
SOLIRIS / SYNAGIS / TYSABRI1:11-cv-00084 (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.

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