Epysqli (eculizumab-aagh)

aBL 761340

Epysqli (eculizumab-aagh)

aBL 761340

U.S. License Holder:

Samsung Bioepis

Date of License:

July-19-2024 (Interchangeable)

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

EPYSQLI (eculizumab-aagh) 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.

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):

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):

1:24-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

Related News

Spotlight On: Biosimilar Litigations
April Breyer Menon Ha Kung Wong
October 31, 2024
Venable’s BiologicsHQ Monthly Injection – September 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
October 11, 2024
Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®
Robert S. Schwartz, Ph.D.
September 3, 2024
Venable’s BiologicsHQ Monthly Injection – July 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
August 10, 2024
FDA Approves Second Soliris® (eculizumab) Interchangeable Biosimilar – Samsung Bioepis’s Epysqli® (eculizumab-aagh)
Robert S. Schwartz, Ph.D.
July 24, 2024
EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates
Robert S. Schwartz Monica Chou Damineh Morsali, Ph.D.
December 31, 2023
Venable’s BiologicsHQ Monthly Injection – May 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 13, 2023

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha