Enbrel® (etanercept)

BL 103795

Enbrel® (etanercept)

BL 103795

U.S. License Holder:

Immunex

Date of License:

November-02-1998

Last Update:

Mar-15-2025

FDA-Approved Indications

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

Adult patients with:

Rheumatoid Arthritis (RA);

Psoriatic Arthritis (PsA);

Ankylosing Spondylitis (AS);

Plaque Psoriasis (PsO);

Pediatric patients with:

Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older;

Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA);

Plaque Psoriasis, 4 years of age or older.

aBLA / 505(b)(2) Activity

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

Erelzi®: Sandoz (August-2016) Eticovo®: Samsung Bioepis (April-2019)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Brenzys (Samsung Bioepis / Merck Canada) (August-2016)
Erelzi (Sandoz) (April-2017)
Rymti® (Lupin) (September-2022)

Biosimilars Approved In The E.U.

Benepali (Samsung Bioepis / Biogen) (January-2016)
Erelzi (Sandoz) (June-2017)
Nepexto (Mylan / Lupin) (June-2020)

Biosimilars Approved In Australia

Brenzys (Samsung Bioepis) (July-2016)
Erelzi (Sandoz) (November-2017)
Etera / Rymti (Alphapharm) (October-2020)

Biosimilars Approved In Japan

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

Biosimilars Approved In South Korea

Davictrel (HD203) (Hanwha Chemical / Merck) (November-2014)
Etoloce (Samsung Bioepis) (September-2015)
Eucept (LG Chem) (March-2018)
YLB133 (Lupin / YL Biologics) (March-2019)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2015-01792

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: Claims 1-10

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

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2017-01916

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

Patent Owner
Hoffman-La Roche Inc.; Amgen Inc.; Amgen Manufacturing Limited; Immunex Corporation

Petitioner(s)
Coherus BioSciences, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-10

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

IPR2017-02066

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

Patent Owner
Hoffman-La Roche Inc.; Amgen Inc.; Amgen Manufacturing Limited; Immunex Corporation

Petitioner(s)
Coherus BioSciences, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-36

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

U.S. Patent Litigations

PACER

Case No(s):

1:09-cv-00805 (D. Del.)

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

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

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

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

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

Enbrel® (etanercept)

Enbrel® (etanercept)

FDA-Approved Indications

aBLA / 505(b)(2) Activity

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

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

Biosimilars Approved In Japan

Biosimilars Approved In South Korea

Inter Partes Review Proceedings

IPR Case No(s):

IPR2015-01792

IPR2017-01916

IPR2017-02066

U.S. Patent Litigations

Case No(s):

1:09-cv-00805 (D. Del.)

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

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

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

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