SB12 (eculizumab)

SB12 Approval Pending

SB12 (eculizumab)

SB12 Approval Pending

U.S. License Holder:

Samsung Bioepis

Date of License:

aBLA accepted by FDA July-2023

Last Update:

Feb-08-2024

approved_indications FDA-Approved Indications


SB12 (eculizumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Epysqli (Samsung Bioepis) (May-2023)

Biosimilars Approved In South Korea

Episcli (Samsung Bioepis) (January-2024)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
9,732,149 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement)

Patent Owner
Alexion Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co. Ltd.

§ 102 Challenge
Y: Claim 1

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claim 1

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
9,718,880 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement)

Patent Owner
Alexion Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co. Ltd.

§ 102 Challenge
Y: Claim 2

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-3

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
9,725,504 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement)

Patent Owner
Alexion Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co. Ltd.

§ 102 Challenge
Y: Claims 1-5, 7-10

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-10

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
10,590,189 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement)

Patent Owner
Alexion Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co. Ltd.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-8

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
10,703,809 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement)

Patent Owner
Alexion Pharmaceuticals, Inc.

Petitioner(s)
Samsung Bioepis Co. Ltd.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-29

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
9,447,176 (Methods and Compositions for Treating Complement-Associated Disorders) 9,718,880 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement) 9,725,504 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement) 9,732,149 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement) 10,590,189 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement) 10,703,809 (Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients by an Inhibitor of Complement)

Plaintiffs
Alexion Pharmaceuticals, Inc.; Alexion Pharma International Operations Ltd.

Defendants
Samsung Bioepis Co., Ltd.

Status
Case Ongoing

BPCIA
Y

Methodology

Information contained in the Venable 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 BiologicsHQ database.

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