GENZYME

GENZYME

approved_indications FDA Approved Biologics and Pending Applications

Campath® / Lemtrada®

alemtuzumab
BL 103948

Cerezyme®

imiglucerase
BL 020367

Fabrazyme®

agalsidase beta
BL 103979

Myozyme® / Lumizyme®

alglucosidase alfa
BL 125141 / BL 125291

Nexviazyme®

avalglucosidase alfa-ngpt
BL 761194

Thyrogen®

thyrotropin alfa
BL 020898

Xenpozyme

olipudase alfa-rpcp
BL 761261

approved_indications Inter Partes Review Proceedings

DUPIXENTIPR2017-01129
IPR2017-01879
IPR2017-01884
GENENTECH CABILLYIPR2016-00383
IPR2016-00460
MYOZYME / LUMIZYMEIPR2013-00534
IPR2013-00535
IPR2013-00537
ZOLGENSMAIPR2023-00608
IPR2023-00609
IPR2023-01044
IPR2023-01045

approved_indications U.S. Patent Litigations

DUPIXENT1:17-cv-10465 (D. Mass.)
2:17-cv-02613 (C.D. Cal.)
ELEVIDYS1:24-cv-00882 (D. Del.)
FABRAZYME1:09-cv-00768 (D. Del.)
ZOLGENSMA1:21-cv-01736 (D. Del.)
1:23-cv-00554 (D. Del.)
CAMPATH / LEMTRADA / GENENTECH CABILLY2:15-cv-09991 (C.D. Cal.)

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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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