Bavencio® (avelumab)

BL 761049 / BL 761078

Bavencio® (avelumab)

BL 761049 / BL 761078

U.S. License Holder:

EMD Serono Inc.

Date of License:

March-23-2017 / May-09-2017

Last Update:

Mar-08-2024

approved_indications FDA-Approved Indications


BAVENCIO (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for:

Merkel Cell Carcinoma (MCC): Adults and pediatric patients 12 years and older with metastatic MCC;

Urothelial Carcinoma (UC): (I) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy; (II) Patients with locally advanced or metastatic UC 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;

Renal Cell Carcinoma (RCC): First-line treatment, in combination with axitinib, of patients with advanced RCC.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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
EMD Serono, Inc.; Merck KGaA; Pfizer Inc.

Status
Stipulated Dismissal Due to Settlement

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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