Soliris® (eculizumab)

BL 125166

Soliris® (eculizumab)

BL 125166

U.S. License Holder:

Alexion Pharm.

Date of License:

March-16-2007

Last Update:

April-15-2019

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 adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

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

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
Institution Decision Pending

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 Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

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 Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

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

related articles Related News Articles

Venable Fitzpatrick’s BiologicsHQ Monthly Injection – February 2019 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. March 6, 2019

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.

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