Darzalex® (daratumumab)

BL 761036

Darzalex® (daratumumab)

BL 761036

U.S. License Holder:

Janssen Biotech

Date of License:

November-16-2015

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


DARZALEX (daratumumab) is a CD38-directed cytolytic antibody indicated:

In combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant;

In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy;

In combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor;

As monotherapy, for the treatment of patients with multiple myeloma 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
Case Ongoing

BPCIA
N

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – October 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. November 3, 2017

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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