Eticovo® — Venable's BiologicsHQ

U.S. License Holder:

Samsung Bioepis Co. Ltd.

Date of License:

April-25-2019

Last Update:

Nov-15-2023

FDA-Approved Indications

ETICOVO (etanercept-ykro) is a tumor necrosis factor (TNF) blocker indicated for the treatment of:

Rheumatoid Arthritis (RA);

Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older;

Psoriatic Arthritis;

Ankylosing Spondylitis (AS);

Plaque Psoriasis (PsO) in patients 4 years or older.

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Brenzys (Samsung Bioepis / Merck Canada) (August-2016)

Biosimilars Approved In The E.U.

Benepali (Samsung Bioepis / Biogen) (January-2016)

Biosimilars Approved In Australia

Brenzys (Samsung Bioepis) (July-2016)

Biosimilars Approved In South Korea

SB4 (Brenzys/Benepali) (Samsung Bioepis) (September-2015)

U.S. Patent Litigations

PACER

Case No(s):

2:19-cv-11755 (D.N.J.)

U.S. Patent Nos.
7,915,225 (Soluble Tumor Necrosis Factor Receptor Treatment of Medical Disorders) 8,063,182 (Human TNF Receptor Fusion Protein) 8,119,605 (Soluble Tumor Necrosis Factor Receptor Treatment of Medical Disorders) 8,163,522 (Human TNF Receptor) 8,722,631 (Soluble Tumor Necrosis Factor Receptor Treatment of Medical Disorders)

Plaintiffs
Amgen Manufacturing, Ltd.; Hoffmann-La Roche Inc.; Immunex Corp.

Defendants
Samsung Bioepis Co., Ltd.; Intervenors: Sandoz GmbH; Sandoz, Inc.; Sandoz International GmbH

Status
Stipulation of Infringement of '182 and '522 Patents, Final Judgment Entered in Favor of Plaintiffs and Permanent Injunction Issued

BPCIA
Y

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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Eticovo® (etanercept-ykro)

Eticovo® (etanercept-ykro)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

Biosimilars Approved In South Korea

U.S. Patent Litigations

Case No(s):

2:19-cv-11755 (D.N.J.)

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