Soliris® (eculizumab)

BL 125166

Soliris® (eculizumab)

BL 125166

U.S. License Holder:

Alexion Pharm.

Date of License:

March-16-2007

Last Update:

February-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 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

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.

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