Darzalex® (daratumumab)

BL 761036

Darzalex® (daratumumab)

BL 761036

U.S. License Holder:

Janssen Biotech

Date of License:

November-16-2015

Last Update:

Mar-08-2024

approved_indications FDA-Approved Indications


DARZALEX (daratumumab) is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma:

In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy;

In combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant;

In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant;

In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy;

in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy;

In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor;

As monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
8,263,746 (Anti-CD38 Human Antibodies and Uses Thereof) 9,200,061 (Generation and Profiling of Fully Human HuCAL Gold®-Derived Therapeutic Antibodies Specific for Human CD3I) 9,758,590 (Anti-CD38 Human Antibodies and Uses Thereof)

Plaintiffs
MorphoSys AG

Defendants
Genmab A/S; Genmab US, Inc.; Janssen Biotech, Inc.

Status
Stipulated Dismissal

BPCIA
N

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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