Ziextenzo® — Venable's BiologicsHQ

U.S. License Holder:

Sandoz

Date of License:

November-04-2019

Last Update:

Nov-15-2024

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;

Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Ziextenzo® (Sandoz) (April-2020)

Biosimilars Approved In The E.U.

Ziextenzo® (Sandoz) (November-2018)

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

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Ziextenzo® (pegfilgrastim-bmez)

Ziextenzo® (pegfilgrastim-bmez)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

U.S. Patent Litigations

Case No(s):

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

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

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

Related News

Filter Results

Or Search By:

Brand Name

Scientific Name

Company Name

Methodology

Disclaimer

Subscribe for Future Updates