Enbrel® (etanercept)

BL 103795

Enbrel® (etanercept)

BL 103795

U.S. License Holder:

Immunex

Date of License:

November-02-1998

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


ENBREL (etanercept) 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 aBLA / 505(b)(2) Activity


aBLA / 505(b)(2) Approved by FDA

Erelzi®: Sandoz (August-2016)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Brenzys (Samsung Bioepis / Merck Canada) (August-2016)
Erelzi (Sandoz) (April-2017)

Biosimilars Approved In The E.U.

Benepali (Samsung Bioepis / Biogen) (January-2016)
Erelzi (Sandoz) (June-2017)

Biosimilars Approved In Australia

Brenzys (Samsung Bioepis) (July-2016)
Erelzi (Sandoz) (November-2017)

Biosimilars Approved In Japan

LBEC0101 (LG Chem Ltd.) (January-2018)

Biosimilars Approved In South Korea

Davictrel (HD203) (Hanwha Chemical / Merck) (November-2014)
Eucept (LG Chem) (March-2018)
SB4 (Brenzys/Benepali) (Samsung Bioepis) (September-2015)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
8,163,522 (Human TNF Receptor)

Patent Owner
Amgen Inc.; Hoffman-La Roche Inc.; Immunex Corp.

Petitioner(s)
Coalition For Affordable Drugs V LLC

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Manufacturing Other (Vector, Host Cell)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent No.
8,163,522 (Human TNF Receptor)

Patent Owner
Hoffman-La Roche Inc.

Petitioner(s)
Coherus BioSciences, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Manufacturing Other (Vector, Host Cell)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

U.S. Patent No.
8,063,182 (Human TNF Receptor Fusion Protein)

Patent Owner
Hoffman-La Roche Inc.

Petitioner(s)
Coherus BioSciences, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

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
Amgen Inc.; Wyeth

Status
Dismissed

BPCIA
N

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

Status
Case Ongoing

BPCIA
Y

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
Case Terminated

BPCIA
N

related articles Related News Articles


Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) April M. Breyer Menon; Joseph K. Yarsky; Corinne E. Atton; Robert S. Schwartz, Ph.D. November 30, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – August 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. September 6, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. August 3, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – April 2018 April M. Breyer Menon; Corinne E. Atton; Joseph K. Yarsky; Robert S. Schwartz, Ph.D. May 3, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – March 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. April 6, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – August/September 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. October 5, 2017
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 26, 2017

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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