Soliris® (eculizumab)

BL 125166

Soliris® (eculizumab)

BL 125166

U.S. License Holder:

Alexion Pharm.

Date of License:

March-16-2007

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

SOLIRIS (eculizumab) is a complement inhibitor indicated for:

The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis;

The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy;

The treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive;

The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

approved_indications aBLA / 505(b)(2) Activity

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

Bkemv: Amgen (May-2024, Interchangeable) Epysqli®: Samsung Bioepis (July-2024, Interchangeable)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Bekemv (Amgen) (April-2023)
Epysqli (Samsung Bioepis) (May-2023)

Biosimilars Approved In South Korea

Epysqli (Samsung Bioepis) (January-2024)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2019-00739

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)
Amgen Inc.

§ 102 Challenge
Y: Claims 1-3, 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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2019-00740

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)
Amgen Inc.

§ 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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2019-00741

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)
Amgen Inc.

§ 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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2023-00933

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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2023-00998

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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2023-00999

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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2023-01069

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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

IPR2023-01070

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

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:11-cv-00084 (D. Del.)

U.S. Patent Nos.
5,688,688 (Vector for Expression of a Polypeptide in a Mammalian Cell)

Plaintiffs
Novartis Pharma AG; Novartis Vaccines and Diagnostics Inc.

Defendants
Alexion Pharmaceuticals, Inc.; Biogen IDEC, Inc.; MedImmune LLC

Status
Dismissed

BPCIA
N

1:24-cv-00005 (D. Del.)

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.

Federal Circuit Appeal(s)
24-1829 (Preliminary Injunction)

Status
Voluntarily Dismissed; Preliminary Injunction Denied; Federal Circuit Appeal (Preliminary Injunction) Voluntarily Dismissed, Motion for Temporary Injunction During Appeal Denied

BPCIA
Y

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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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