Erelzi® (etanercept-szzs)

aBL 761042

Erelzi® (etanercept-szzs)

aBL 761042

U.S. License Holder:

Sandoz Inc.

Date of License:


Last Update:


approved_indications FDA-Approved Indications

ERELZI (etanercept-szzs) 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 (PsA);

Ankylosing Spondylitis (AS);

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

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Erelzi (Sandoz) (April-2017)

Biosimilars Approved In The E.U.

Erelzi (Sandoz) (June-2017)

approved_indications U.S. Patent Litigations


Case No(s):

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)

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

Sandoz GmbH; Sandoz, Inc.; Sandoz International GmbH

Federal Circuit Appeal(s)

Supreme Court Appeal(s)

District Court Determination that Patents Not Invalid, Stipulation of Infringement; Permanent Injunction Issued; Federal Circuit Affirmed, Petition for Panel Rehearing and En Banc Rehearing Denied; Petition for Writ of Certiorari Denied


U.S. Patent Nos.
8,063,182 (Human TNF Receptor Fusion Protein) 8,163,522 (Human TNF Receptor)

Sandoz, Inc.

Amgen Inc.; Hoffmann-La Roche, Inc.

Federal Circuit Appeal(s)

Complaint Dismissed for Lack of Subject Matter Jurisdiction; Federal Circuit Affirmed



Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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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