Nivestym® (filgrastim-aafi)

aBL 761080

Nivestym® (filgrastim-aafi)

aBL 761080

U.S. License Holder:

Pfizer Inc.

Date of License:

July-20-2018

Last Update:

Sep-30-2024

approved_indications FDA-Approved Indications


NIVESTYM (filgrastim-aafi) is a leukocyte growth factor indicated to:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever;

Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML);

Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT);

Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis;

Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Nivestym® (Pfizer) (April-2020)

Biosimilars Approved In The E.U.

Nivestim® (Hospira) (June-2010)

Biosimilars Approved In Australia

Nivestim® (Pfizer) (September-2010)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
8,273,707 (Process for Purifying Proteins)

Patent Owner
Amgen Inc.

Petitioner(s)
Hospira, Inc.; Pfizer Inc.

§ 102 Challenge
Y: Claims 1, 2, 4, 8, 10, and 11

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 2, 4, 8, 10, and 11

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated After Institution Due to Settlement

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Hospira, Inc.; Pfizer Inc.

Status
Settled

BPCIA
Y

U.S. Patent Nos.
10,577,392 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Hospira, Inc.; Pfizer Inc.

Status
Settled

BPCIA
Y

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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