ASTRAZENECA

FDA Approved Biologics and Pending Applications

Beyfortus

nirsevimab-alip
BL 761328

Fasenra®

benralizumab
BL 761070

Imfinzi®

durvalumab
BL 761069

Imjudo®

tremelimumab-actl
BL 761289

Lumoxiti®

moxetumomab pasudotox-tdfk
BL 761104

Saphnelo®

anifrolumab-fnia
BL 761123

Tezspire®

tezepelumab-ekko
BL 761224

Inter Partes Review Proceedings

ENHERTU / ADCETRISPGR2021-00030
PGR2021-00042

U.S. Patent Litigations

ENHERTU / ADCETRIS1:20-cv-01524 (D. Del.)
2:20-cv-00337 (E.D. Tex.)
OPDIVO / IMFINZI1:17-cv-01028 (D. Del.)
1:22-cv-00346 (D. Del.)
1:23-cv-00459 (D. Del.)
YERVOY / IMJUDO1:23-cv-00079 (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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