Stimufend® (pegfilgrastim)

Stimufend® Approval Pending

Stimufend® (pegfilgrastim)

Stimufend® Approval Pending

U.S. License Holder:

Fresenius Kabi

Date of License:

aBLA accepted by FDA May-2020

Last Update:

May-15-2022

approved_indications FDA-Approved Indications

Stimufend® (pegfilgrastim) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Stimufend® (Fresenius Kabi) (March-2022)

approved_indications 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

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2020-00314

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

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

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 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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