MSB11456 (tocilizumab)

MSB11456 Approval Pending

MSB11456 (tocilizumab)

MSB11456 Approval Pending

U.S. License Holder:

Fresenius Kabi

Date of License:

aBLA accepted by FDA August-2022

Last Update:

September-30-2022

approved_indications FDA-Approved Indications


MSB11456 (tocilizumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted; Pending

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
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted; Pending

U.S. Patent No.
8,580,264 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Genentech, Inc.; Hoffmann-La Roche Inc.

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
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted; Pending

U.S. Patent No.
10,874,677 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.

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
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

IPR Status
Instituted; Pending

U.S. Patent No.
8,580,264 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Genentech, Inc.; Hoffmann-La Roche Inc.

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
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted; Pending

U.S. Patent No.
9,750,752 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.

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

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted; Pending

U.S. Patent No.
10,231,981 (Subcutaneously Administered Anti-IL6 Receptor Antibody for Treatment of Juvenile Idiopathic Arthritis)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, LLC; 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

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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