Neupogen® — Venable's BiologicsHQ

U.S. License Holder:

Amgen

Date of License:

February-20-1991

Last Update:

Sep-30-2024

FDA-Approved Indications

NEUPOGEN (filgrastim) 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);

Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis;

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;

Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).

aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Zarxio®: Sandoz (March-2015) Nivestym®: Pfizer (July-2018) Releuko®: Kashiv BioSciences (February-2022) Nypozi (Tanvex BioPharma) (June-2024)

aBLA / 505(b)(2) Accepted by FDA

Grastofil: Apotex (February-2015) Accofil® (Accord BioPharma) (Submission Date Undisclosed)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Grastofil (Apotex) (December-2015)
Nivestym® (Pfizer) (April-2020)
Nypozi (Tanvex Biopharma USA) (October-2021)

Biosimilars Approved In The E.U.

Accofil® (Accord Healthcare) (September-2014)
Biograstim (CT Arzneimittel) (September-2008)
Filgrastim Hexal (Hexal) (February-2009)
Grastofil (Apotex) (October-2013)
Nivestim® (Hospira) (June-2010)
Ratiograstim (Ratiopharm GmbH) (September-2008)
Tevagrastim (Teva Generics) (September-2008)
Zarzio (Sandoz) (February-2009)

Biosimilars Approved In Australia

Nivestim® (Pfizer) (September-2010)
Tevagrastim (Teva Pharma Australia) (August-2011)
Zarzio (Sandoz) (May-2013)

Biosimilars Approved In Japan

Filgrastim BS (Fuji Pharma Mochida Pharmaceutical) (November-2012)
Filgrastim BS (Sandoz) (March-2014)
Filgrastim BS (Teva Pharma Japan / Nippon Kayaku) (February-2013)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01542

U.S. Patent No.
8,952,138 (Refolding Proteins Using a Chemically Controlled Redox State)

Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.

Petitioner(s)
Apotex Inc.; Apotex Corp.

§ 102 Challenge
Y: Claims 1-7, 10, 12-17, 19, 22-23

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-24

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-2171

Supreme Court Appeal(s)
20-74

IPR Status
Final Written Decision (Most Challenged Claims Unpatentable, 1 Claim Not Unpatentable); Request for Rehearing Determined All Claims Unpatentable; Petition for Writ of Certiorari Granted, Vacating and Remanding to the Federal Circuit for Consideration in Light of Arthrex; Federal Circuit Vacated and Remanded Due to Arthrex; Joint Motion to Terminate Remand Pending; Request for Director Review Denied; Federal Circuit Reversed (No Claims Found Unpatentable)

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

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

IPR2021-00326

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

Patent Owner
Amgen Inc.

Petitioner(s)
Lupin Limited; Lupin Pharmaceuticals, Inc.; Lupin Inc.; Nanomi BV

§ 102 Challenge
Y: Claims 1-4, 7-19, 22-30

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2021-00528

U.S. Patent No.
8,273,707 (Process for Purifying Proteins)

Patent Owner
Amgen Inc.

Petitioner(s)
Hospira, Inc.; Pfizer Inc.

§ 102 Challenge
Y: Claims 1, 2, 4, 8, 10, and 11

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 2, 4, 8, 10, and 11

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

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

IPR Status
Terminated After Institution Due to Settlement

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

U.S. Patent Litigations

PACER

Case No(s):

0:15-cv-62081 (S.D. Fla.)

U.S. Patent Nos.
6,162,427 (Combination of G-CSF with a Chemotherapeutic Agent for Stem Cell Mobilization) 8,952,138 (Refolding Proteins using a Chemically Controlled Redox State)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Apotex, Inc.; Apotex Corp.

Federal Circuit Appeal(s)
17-1010

Status
Consolidated with 0:15-cv-61631 (S.D. Fla.); District Court: '427 Patent Settled, '138 Patent Not Infringed, Not Unenforceable, Invalidity Dismissed; Affirmed on Appeal (17-1010)

BPCIA
Y

0:18-cv-61828 (S.D. Fla.)

U.S. Patent Nos.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Apotex Corp.; Apotex Inc.; Accord BioPharma

Status
Stipulated Dismissal

BPCIA
Y

1:10-cv-01540 (E.D. Ill.)

U.S. Patent Nos.
4,810,643 (Production of Pluripotent Granulocyte Colony-Stimulating Factor) 4,999,291 (Production of Pluripotent Granulocyte Colony-Stimulating Factor) 4,999,299 (Propagation Process Employing Agarose Medium) 5,621,080 (Production of Erythropoietin)

Plaintiffs
Thomas A. Simonian

Defendants
Amgen Inc.

Status
Case Terminated

BPCIA
N

1:18-cv-01064 (D. Del.)

U.S. Patent Nos.
9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Hospira, Inc.; Pfizer Inc.

Status
Settled

BPCIA
Y

1:20-cv-00561 (D. Del.)

U.S. Patent Nos.
10,577,392 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Hospira, Inc.; Pfizer Inc.

Status
Settled

BPCIA
Y

2:13-cv-04911 (D.N.J.)

U.S. Patent Nos.
8,058,398 (Modified G-CSF Polypeptide)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Teva Biopharmaceuticals USA, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Status
Dismissed

BPCIA
N

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

3:14-cv-04741 (N.D. Cal.)

U.S. Patent Nos.
6,162,427 (Combination of G-CSF with a Chemotherapeutic Agent for Stem Cell Mobilization) 8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Sandoz International GmbH; Sandoz GmbH; Sandoz Inc.

Federal Circuit Appeal(s)
15-1499 18-1551

Supreme Court Appeal(s)
15-1039 (U.S.) 15-1195 (U.S.)

Status
BPCIA Interpretation: Supreme Court Vacated-in-Part, Reversed-in-Part, and Remanded; Remand to Federal Circuit: Affirmed. Infringement and Validity: Summary Judgment of Non-infringement and Invalidity Counterclaims Dismissed; Federal Circuit Affirmed, Petition for En Banc Rehearing Granted-in-Part and Denied-in-Part

BPCIA
Y

3:19-cv-00977 (N.D. Cal.)

U.S. Patent Nos.
9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Sandoz, Inc.

Defendants
Amgen Manufacturing, Ltd.; Amgen Inc.

Status
Voluntarily Dismissed

BPCIA
N

3:19-cv-01374 (S.D. Cal.)

U.S. Patent Nos.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)

Plaintiffs
Amgen Manufacturing, Ltd.; Amgen Inc.

Defendants
Tanvex Biologics Corp.; Tanvex Biopharma, Inc.; Tanvex BioPharma USA, Inc.

Status
Stipulated Dismissal

BPCIA
Y

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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Neupogen® (filgrastim)

Neupogen® (filgrastim)

FDA-Approved Indications

aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

aBLA / 505(b)(2) Accepted by FDA

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

Biosimilars Approved In Japan

Inter Partes Review Proceedings

IPR Case No(s):

IPR2016-01542

IPR2019-00791

IPR2019-00797

IPR2019-01183

IPR2021-00326

IPR2021-00528

PGR2019-00001

U.S. Patent Litigations

Case No(s):

0:15-cv-62081 (S.D. Fla.)

0:18-cv-61828 (S.D. Fla.)

1:10-cv-01540 (E.D. Ill.)

1:18-cv-01064 (D. Del.)

1:20-cv-00561 (D. Del.)

2:13-cv-04911 (D.N.J.)

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

3:14-cv-04741 (N.D. Cal.)

3:19-cv-00977 (N.D. Cal.)

3:19-cv-01374 (S.D. Cal.)

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