Ultomiris® (ravulizumab-cwvz)

BL 761108

Ultomiris® (ravulizumab-cwvz)

BL 761108

U.S. License Holder:

Alexion Pharm.

Date of License:

December-21-2018

Last Update:

June-30-2025

approved_indications FDA-Approved Indications

ULTOMIRIS (ravulizumab-cwvz) is a complement inhibitor indicated for:

The treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH);

The treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (™A);

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

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:18-cv-01802 (D. Del.)

U.S. Patent Nos.
9,890,377 (Antigen-Binding Molecule Capable of Binding Two or More Antigen Molecules Repeatedly)

Plaintiffs
Chugai Pharmaceuticals Co., Ltd.

Defendants
Alexion Pharmaceuticals, Inc.

Status
Stipulated Dismissal

BPCIA
N

1:19-cv-02120 (D. Del.)

U.S. Patent Nos.
10,472,623 (Antigen-Binding Molecule Capable of Binding Two or More Antigen Molecules Repeatedly)

Plaintiffs
Chugai Pharmaceuticals Co., Ltd.

Defendants
Alexion Pharmaceuticals, Inc.

Status
Stipulated Dismissal

BPCIA
N

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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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