Granix® (tbo-filgrastim)

BL 125294

Granix® (tbo-filgrastim)

BL 125294

U.S. License Holder:

Sicor Biotech (Teva)

Date of License:

August-29-2012

Last Update:

Oct-23-2024

approved_indications FDA-Approved Indications


GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
8,058,398 (Modified G-CSF Polypeptide)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Teva Biopharmaceuticals USA, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Status
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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