Elitek® (rasburicase)

BL 103946

Elitek® (rasburicase)

BL 103946

U.S. License Holder:

Sanofi Synthelabo

Date of License:

July-12-2002

Last Update:

Mar-08-2024

approved_indications FDA-Approved Indications


ELITEK (rasburicase) is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
5,919,651 (Expression of Polypeptides in Yeast)

Plaintiffs
Genentech, Inc.; Washington Research Foundation

Defendants
Sanofi; Sanofi-Synthelabo LLC; Synthelabo LLC; Sanofi-Aventis US LLC

Federal Circuit Appeal(s)
18-1612

Status
Summary Judgment of Noninfringement Granted; Federal Circuit Appeal Voluntarily Dismissed

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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