Releuko® (filgrastim-ayow)

aBL 761082

Releuko® (filgrastim-ayow)

aBL 761082

U.S. License Holder:

Kashiv BioSciences

Date of License:

February-25-2022

Last Update:

Feb-15-2025

approved_indications FDA-Approved Indications

RELEUKO (filgrastim-ayow) is a leukocyte growth factor indicated to:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever;

Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML);

Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT);

Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic 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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:18-cv-03347 (D.N.J.)

U.S. Patent Nos.
6,180,391 (Highly Efficient Controlled Expression of Exogenous Genes in E. Coli) 7,083,948 (Polypeptide Purification Reagents and Methods for Their Use) 7,118,884 (Method for Controlling Metallophosphate Precipitation in High Cell Density Fermentations) 7,384,765 (Cell Culture Performance with Betaine) 7,427,659 (Process for Purifying Proteins in a Hydrophobic Interaction Chromatography Flow-Through Fraction) 7,662,930 (Polishing Steps Used in Multi-Step Protein Purification Processes) 7,735,525 (Thermally Insulated Apparatus for Liquid Chromatographic Analysis) 7,781,395 (Process for Purifying Proteins) 8,191,566 (Valve for Controlling the Flow of Steam and Other Fluids) 8,273,707 (Process for Purifying Proteins) 8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System) 8,952,138 (Refolding Proteins using a Chemically Controlled Redox State) 9,418,416 (Methods and Apparati for Nondestructive Detection of Undissolved Particles in a Fluid) 9,632,095 (Device and Method for Determining Reaction Kinetics) 9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System) 9,704.239 (Video Trigger Synchronization for Improved Particle Detection in a Vessel) 9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Adello Biologics, LLC; Amneal Pharmaceuticals, Inc.; Amneal Pharmaceuticals LLC; Kashiv BioSciences, LLC

Status
Stipulated Dismissal

BPCIA
Y

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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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