Ultomiris® (ravulizumab-cwvz)

BL 761108

Ultomiris® (ravulizumab-cwvz)

BL 761108

U.S. License Holder:

Alexion Pharm.

Date of License:

December-21-2018

Last Update:

Nov-15-2024

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

Related News

Venable’s BiologicsHQ Monthly Injection – March 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 18, 2022
Venable’s BiologicsHQ Monthly Injection – November 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
December 9, 2019
Venable’s BiologicsHQ Monthly Injection – December 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
January 9, 2019

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