Actemra® (tocilizumab)

BL 125276 [BL 125472]

Actemra® (tocilizumab)

BL 125276 [BL 125472]

U.S. License Holder:

Genentech

Date of License:

January-08-2010 [October-21-2013]

Last Update:

July-23-2021

approved_indications FDA-Approved Indications

ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

Rheumatoid Arthritis (RA): Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs);

Giant Cell Arteritis (GCA): Adult patients with giant cell arteritis;

Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis;

Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active systemic juvenile idiopathic arthritis;

Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2021-01024

U.S. Patent No.
7,521,052 (Methods for Treating Interleukin-6 Related Diseases)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius SE & Co. KGaA

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

IPR2021-01025

U.S. Patent No.
10,744,201 (Method for Treating Rheumatoid Arthritis with a Human IL-6 Receptor Antibody and Methotrexate)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius SE & Co. KGaA

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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Methodology

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