Stimufend® — Venable's BiologicsHQ

U.S. License Holder:

Fresenius Kabi

Date of License:

September-01-2022

Last Update:

June-23-2025

FDA-Approved Indications

STIMUFEND (pegfilgrastim-fpgk) 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 The E.U.

Stimufend® (Fresenius Kabi) (March-2022)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2019-00971

U.S. Patent No.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)

Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius Kabi SwissBioSim GmbH; Fresenius SE & Co. KGaA; Dr. Reddy's Laboratories Inc.; Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, SA

§ 102 Challenge
Y: Claims 1, 4, 8-10, 12, 14-16, 19-21, 23-26, 29-30

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1, 4-6, 8-10, 12, 14-16, 19-21, 23-26, 29-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2019-01183

U.S. Patent No.
9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Patent Owner
Amgen Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius Kabi Swiss BioSim GmbH; Fresenius SE & Co. KGaA; Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, SA

§ 102 Challenge
Y: Claims 9-10, 13-21, 23-30

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 9-10, 13-21, 23-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

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

IPR Status
Settled After Institution Decision

IPR2020-00314

U.S. Patent No.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)

Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.

§ 102 Challenge
Y: Claims 1, 4, 8-10, 12, 14-16, 19-21, 23-26, 29-30

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 4-6, 8-10, 12, 14-16, 19-21, 23-26, 29-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

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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Stimufend® (pegfilgrastim-fpgk)

Stimufend® (pegfilgrastim-fpgk)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Inter Partes Review Proceedings

IPR Case No(s):

IPR2019-00971

IPR2019-01183

IPR2020-00314

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