Benlysta® (belimumab)

BL 125370 [BL 761043]

Benlysta® (belimumab)

BL 125370 [BL 761043]

U.S. License Holder:

Human Genome Sciences Inc. [GlaxoSmithKline]

Date of License:

March-09-2011 [July-20-2017]

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

BENLYSTA (belimumab) is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of:

Patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy;

Patients aged 5 years and older with active lupus nephritis who are receiving standard therapy.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:11-cv-00082 (D. Del.)

U.S. Patent Nos.
4,816,567 (Recombinant Immunoglobin Preparations)

Plaintiffs
Human Genome Sciences Inc.

Defendants
City Of Hope; Genentech, Inc.

Status
Transferred (2:11-cv-06519 (C.D. Cal.))

BPCIA
N

1:11-cv-00328 (D. Del.)

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Human Genome Sciences Inc.

Defendants
City Of Hope; Genentech, Inc.

Status
Transferred (2:11-cv-06594 (C.D. Cal.))

BPCIA
N

2:11-cv-03065 (C.D. Cal.)

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
City Of Hope; Genentech, Inc.

Defendants
Glaxo Group Ltd; GlaxoSmithKline LLC; Human Genome Sciences Inc.; Lonza Biologics Inc.; Lonza Biologics PLC

Status
Dismissed

BPCIA
N

2:11-cv-06519 (C.D. Cal.)

U.S. Patent Nos.
4,816,567 (Recombinant Immunoglobin Preparations) 6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein)

Plaintiffs
Human Genome Sciences Inc.; Glaxo Group Ltd; GlaxoSmithKline LLC

Defendants
City Of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

2:11-cv-06594 (C.D. Cal.)

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
GlaxoSmithKline LLC; Human Genome Sciences Inc.

Defendants
City Of Hope; Genentech, Inc.

Status
Dismissed

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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