Imfinzi® (durvalumab)

BL 761069

Imfinzi® (durvalumab)

BL 761069

U.S. License Holder:

AstraZeneca UK Ltd.

Date of License:

May-01-2017

Last Update:

January-15-2023

approved_indications FDA-Approved Indications

IMFINZI (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

For the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy;

In combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations;

In combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC);

In combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC);

In combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

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

1:22-cv-00346 (D. Del.)

U.S. Patent Nos.
9,580,505 (Human Monoclonal Antibodies to Programmed Death Ligand 1 (PD-L1) 9,580,507 (Human Monoclonal Antibodies to Programmed Death Ligand 1 (PD-L1) 10,138,299 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,594 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,595 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,596 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,308,714 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,323,092 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons, LLC

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Case Ongoing

BPCIA
N

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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