Elaprase® (idursulfase)

BL 125151

Elaprase® (idursulfase)

BL 125151

U.S. License Holder:

Shire

Date of License:

July-24-2006

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


ELAPRASE (idursulfase) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
9,051,556 (Purification of iduronate-2-sulfatase)

Patent Owner
Shire Human Genetic Therapies, Inc.; Shire Luxembourg Intellectual Property No 3 Sarl, Irish Branch; Shire Orphan and Rare Diseases GmbH; Shire Pharmaceuticals International; Shire PLC

Petitioner(s)
Green Cross Corp.; Green Cross Holdings Corp.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable)

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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