Imjudo® (tremelimumab-actl)

BL 761289

Imjudo® (tremelimumab-actl)

BL 761289

U.S. License Holder:

AstraZeneca AB

Date of License:

October-21-2022

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

IMJUDO (tremelimumab-actl) is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated:

In combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC);

In combination with durvalumab 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) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-00079 (D. Del.)

U.S. Patent Nos.
9,273,135 (Human Monoclonal Antibodies to Programmed Death Ligand 1 (PD-L1) 9,320.811 (Combination of Anti-CTLA4 Antibody with Diverse Therapeutic Regimens for the Synergistic Treatment of Proliferative Diseases)

Plaintiffs
Bristol-Myers Squibb Co.; ER Squibb & Sons, LLC

Defendants
AstraZeneca AB; AstraZeneca Pharmaceuticals LP

Status
Stipulated Dismissal

BPCIA
N

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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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