Imfinzi (durvalumab)

BL 761069

Imfinzi (durvalumab)

BL 761069

U.S. License Holder:

AstraZeneca UK Ltd.

Date of License:

May-01-2017

Last Update:

August-15-2019

approved_indications FDA-Approved Indications

IMFINZI (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with:

Locally advanced or metastatic urothelial carcinoma who: Have disease progression during or following platinum-containing chemotherapy; Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;

Unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:17-cv-01028 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Stipulated Dismissal

BPCIA
N

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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