Campath® / Lemtrada® (alemtuzumab)

BL 103948

Campath® / Lemtrada® (alemtuzumab)

BL 103948

U.S. License Holder:

Genzyme

Date of License:

May-07-2001

Last Update:

May-15-2022

approved_indications FDA-Approved Indications

LEMTRADA (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

CAMPATH (alemtuzumab) is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:15-cv-09991 (C.D. Cal.)

U.S. Patent Nos.
7,923,221 (Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen)

Plaintiffs
Genzyme Corp.

Defendants
City of Hope; Genentech, Inc.

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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