Ziextenzo® (pegfilgrastim-bmez)

aBL 761045

Ziextenzo® (pegfilgrastim-bmez)

aBL 761045

U.S. License Holder:

Sandoz

Date of License:

November-04-2019

Last Update:

November-23-2020

approved_indications FDA-Approved Indications

ZIEXTENZO (pegfilgrastim-bmez) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Ziextenzo® (Sandoz) (April-2020)

Biosimilars Approved In The E.U.

Ziextenzo® (Sandoz) (November-2018)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:16-cv-01276 (D.N.J.)

U.S. Patent Nos.
5,824,784 (N-Terminally Chemically Modified Protein Compositions and Methods) 8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

Status
Dismissed

BPCIA
Y

3:16-cv-02581 (N.D. Cal.)

U.S. Patent Nos.
5,824,784 (N-terminally Chemically Modified Protein Compositions and Methods) 8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Lek Pharmaceuticals d.d.; Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

Federal Circuit Appeal(s)
18-1552 (Consolidated with 18-1551)

Status
Joint Stipulation of Dismissal Relating to U.S. Patent No. 5,824,784; Summary Judgment of Non-Infringement of U.S. Patent No. 8,940,878 Granted; Federal Circuit Affirmed, Petition for En Banc Rehearing Granted-in-Part and Denied-in-Part

BPCIA
Y

3:19-cv-00977 (N.D. Cal.)

U.S. Patent Nos.
9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Sandoz, Inc.

Defendants
Amgen Manufacturing, Ltd.; Amgen Inc.

Status
Voluntarily Dismissed

BPCIA
N

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – June 2020 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong July 9, 2020
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – November 2019 April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. December 9, 2019
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – November 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. December 11, 2018

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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