Cimzia® (certolizumab pegol)

BL 125160

Cimzia® (certolizumab pegol)

BL 125160

U.S. License Holder:

UCB Inc.

Date of License:

April-22-2008

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


CIMZIA (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated for:

Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy;

Treatment of adults with moderately to severely active rheumatoid arthritis;

Treatment of adult patients with active psoriatic arthritis;

Treatment of adults with active ankylosing spondylitis;

Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
6,270,766 (Anti-TNF Antibodies and Methotrexate in the Treatment of Arthritis and Crohn's Disease)

Plaintiffs
Mathilda and Terence Kennedy Institute of Rheumatology Trust

Defendants
UCB, Inc.

Status
Dismissed

BPCIA
N

U.S. Patent Nos.
6,090,923 (Murine Monoclonal Antibody Binding TNF-Alpha)

Plaintiffs
UCB, Inc.

Defendants
Yeda Research and Development Co., Ltd

Federal Circuit Appeal(s)
15-1959 (Fourth Circuit) 2015-1957 (Fed. Cir.)

Status
Dismissed

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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