Fabrazyme® (agalsidase beta)

BL 103979

Fabrazyme® (agalsidase beta)

BL 103979

U.S. License Holder:

Genyzme

Date of License:

April-24-2003

Last Update:

September-23-2022

approved_indications FDA-Approved Indications

FABRAZYME (agalsidase beta) is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Japan

Agalsidase Beta BS (JCR Pharmaceuticals) (November-2018)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:09-cv-00768 (D. Del.)

U.S. Patent Nos.
7,011,831 (Recombinant Alpha-Galactosidase A Therapy for Fabry Disease)

Plaintiffs
Shelbyzyme LLC

Defendants
Genzyme Corp.

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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