Fylnetra (pegfilgrastim-pbbk)

aBL 761084

Fylnetra (pegfilgrastim-pbbk)

aBL 761084

U.S. License Holder:

Kashiv Biosciences LLC / Amneal

Date of License:

May-26-2022

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

FYLNETRA (pegfilgrastim-pbbk) 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 Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2019-00791

U.S. Patent No.
8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Patent Owner
Amgen Inc.

Petitioner(s)
Kashiv BioSciences, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC

§ 102 Challenge
Y: Claims 7-8, 11-12, 15-16, 18-19, 21

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 7-8, 11-13, 15-19, 21

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

IPR2019-00797

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

Patent Owner
Amgen Inc.

Petitioner(s)
Kashiv BioSciences, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC

§ 102 Challenge
Y: Claims 9-10, 13-15, 17-21, 23, 26-30

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 9-10, 13-15, 17-21, 23, 26-30

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

PGR2019-00001

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

Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.

Petitioner(s)
Adello Biologics, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC; ApoPharma USA, Inc.; Apotex Corp.; Apotex Holdings, Inc.; Apotex Inc.; Apotex Pharmaceutical Holdings Inc.; Intas Pharmaceuticals Ltd.; Kashiv BioSciences, LLC

§ 102 Challenge
Y: Claims 1-4, 7-19, 22-3

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

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

IPR Status
Challenges Also Include Indefiniteness (Claims 1-15), Written Description (Claims 1-9, 16-25), and Enablement (Claims 1-30). Settled After Institution Decision

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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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