Bkemv (eculizumab-aeeb)

aBL 761333

Bkemv (eculizumab-aeeb)

aBL 761333

U.S. License Holder:

Amgen

Date of License:

May-28-2024 (Interchangeable)

Last Update:

August-08-2026

approved_indications FDA-Approved Indications

BKEMV (eculizumab-aeeb) 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.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Bekemv (Amgen) (April-2026)

Biosimilars Approved In The E.U.

Bekemv (Amgen) (April-2023)

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

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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