Erelzi® — Venable Fitzpatrick's BiologicsHQ

U.S. License Holder:

Sandoz Inc.

Date of License:

August-30-2016

Last Update:

September-23-2022

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;

Ankylosing Spondylitis (AS);

Plaque Psoriasis (PsO) in adults.

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Erelzi (Sandoz) (April-2017)

Biosimilars Approved In The E.U.

Erelzi (Sandoz) (June-2017)

U.S. Patent Litigations

PACER

Case No(s):

2:16-cv-01118 (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
Sandoz GmbH; Sandoz, Inc.; Sandoz International GmbH

Federal Circuit Appeal(s)
20-1037

Supreme Court Appeal(s)
20-1110

Status
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

BPCIA
Y

3:13-cv-02904 (N.D. Cal.)

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

Plaintiffs
Sandoz, Inc.

Defendants
Amgen Inc.; Hoffmann-La Roche, Inc.

Federal Circuit Appeal(s)
14-1693

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

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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Erelzi® (etanercept-szzs)

Erelzi® (etanercept-szzs)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

U.S. Patent Litigations

Case No(s):

2:16-cv-01118 (D.N.J.)

3:13-cv-02904 (N.D. Cal.)

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