Nyvepria® — Venable's BiologicsHQ

U.S. License Holder:

Hospira Inc.

Date of License:

June-10-2020

Last Update:

Nov-15-2024

FDA-Approved Indications

NYVEPRIA (pegfilgrastim-apgf) 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 Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Nyvepria® (Pfizer) (November-2020)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2021-00528

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

U.S. Patent Litigations

PACER

Case No(s):

1:20-cv-00201 (D. Del.)

U.S. Patent Nos.
8,273,707 (Process for Purifying Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Hospira, Inc; Pfizer Inc.

Status
Stipulated Dismissal Due to Settlement

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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Nyvepria® (pegfilgrastim-apgf)

Nyvepria® (pegfilgrastim-apgf)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Inter Partes Review Proceedings

IPR Case No(s):

IPR2021-00528

U.S. Patent Litigations

Case No(s):

1:20-cv-00201 (D. Del.)

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