Stimufend® (pegfilgrastim-fpgk)

aBL 761173

Stimufend® (pegfilgrastim-fpgk)

aBL 761173

U.S. License Holder:

Fresenius Kabi

Date of License:

September-01-2022

Last Update:

September-23-2022

approved_indications 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.

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):

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

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

related articles Related News Articles


Venable Fitzpatrick’s BiologicsHQ Monthly Injection – March 2022 April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong April 18, 2022

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.

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.

Subscribe for Future Updates

    captcha