Neulasta® (pegfilgrastim)

BL 125031

Neulasta® (pegfilgrastim)

BL 125031

U.S. License Holder:

Amgen

Date of License:

January-31-2002

Last Update:

Nov-30-2023

FDA-Approved Indications

NEULASTA (pegfilgrastim) 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;

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

aBLA / 505(b)(2) Activity

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

Fulphila® (Mylan/Biocon) (June-2018) Udenyca® (Coherus) (November-2018) Ziextenzo® (Sandoz) (November-2019) Nyvepria® (Hospira) (June-2020) Fylnetra (Kashiv Biosciences / Amneal) (May-2022) Stimufend®: Fresenius Kabi (September-2022)

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

Lapelga: Apotex (December-2014) Pegfilgrastim (Lupin) (June-2021)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Fulphila® (Mylan) (May-2019)
Lapelga (Apotex) (April-2018)
Ziextenzo® (Sandoz) (April-2020)

Biosimilars Approved In The E.U.

Fulphila® (Mylan) (November-2018)
Grasutek (Juta Pharma) (June-2019)
Nyvepria® (Pfizer) (November-2020)
Pegfilgrastim Mundipharma (Mundipharma Biologics) (December-2019)
Pelgraz (Accord Healthcare) (September-2018)
Pelmeg (Cinfa Biotech) (November-2018)
Stimufend® (Fresenius Kabi) (March-2022)
Ziextenzo® (Sandoz) (November-2018)

Biosimilars Approved In Australia

Fulphila® (Alphapharm / Mylan / Biocon) (August-2018)

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

IPR2019-00971

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: Claims 1, 4, 8-10, 12, 14-16, 19-21, 23-26, 29-30

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 1, 4-6, 8-10, 12, 14-16, 19-21, 23-26, 29-30

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

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

IPR2020-00314

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

Patent Owner
Amgen Inc.; Amgen Manufacturing Ltd.

§ 102 Challenge
Y: Claims 1, 4, 8-10, 12, 14-16, 19-21, 23-26, 29-30

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 4-6, 8-10, 12, 14-16, 19-21, 23-26, 29-30

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

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-61631 (S.D. Fla.)

U.S. Patent Nos.
5,824,784 (N-Terminally Chemically Modified Protein Compositions and Methods) 8,952,138 (Refolding Proteins using a Chemically Controlled Redox State)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Apotex Corp.; Apotex Inc.

Federal Circuit Appeal(s)
16-1308 (Preliminary Injunction) 17-1010

Supreme Court Appeal(s)
16-332 (U.S.) (Preliminary Injunction)

Status
Preliminary Injunction: District Court Granted, Affirmed on Appeal (16-1308), Supreme Court Cert Denied. District Court: '784 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

1:17-cv-00546 (D. Del.)

U.S. Patent Nos.
8,273,707 (Process for Purifying Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Coherus Biosciences Inc.

Federal Circuit Appeal(s)
18-1993

Status
Dismissed for Failure to State a Claim; Federal Circuit Affirmed

BPCIA
Y

1:20-cv-00201 (D. Del.)

U.S. Patent Nos.
8,273,707 (Process for Purifying Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Hospira, Inc; Pfizer Inc.

Status
Stipulated Dismissal Due to Settlement

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

2:16-cv-01276 (D.N.J.)

U.S. Patent Nos.
5,824,784 (N-Terminally Chemically Modified Protein Compositions and Methods) 8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

Status
Dismissed

BPCIA
Y

2:17-cv-01235 (W.D. Pa.)

U.S. Patent Nos.
8,273,707 (Process for Purifying Proteins) 9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Mylan Inc.; Mylan GmbH; Mylan NV; Mylan Pharmaceuticals, Inc.

Status
Terminated: Judgment of Non-Infringement of '707 Patent Entered; Stipulated to Non-Infringement of '997 Patent

BPCIA
Y

3:16-cv-02581 (N.D. Cal.)

U.S. Patent Nos.
5,824,784 (N-terminally Chemically Modified Protein Compositions and Methods) 8,940,878 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)

Plaintiffs
Amgen Inc.; Amgen Manufacturing, Ltd.

Defendants
Lek Pharmaceuticals d.d.; Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

Federal Circuit Appeal(s)
18-1552 (Consolidated with 18-1551)

Status
Joint Stipulation of Dismissal Relating to U.S. Patent No. 5,824,784; Summary Judgment of Non-Infringement of U.S. Patent No. 8,940,878 Granted; 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

56-2017-00493553-CU-BT-VTA (CA Sup. Ct.)

U.S. Patent Nos.
[None Listed]

Plaintiffs
Amgen Inc.

Defendants
Coherus Biosciences Inc.

Status
Settled

BPCIA
N

Neulasta® (pegfilgrastim)

Neulasta® (pegfilgrastim)

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

Inter Partes Review Proceedings

IPR Case No(s):

IPR2016-01542

IPR2019-00791

IPR2019-00797

IPR2019-00971

IPR2019-01183

IPR2020-00314

IPR2021-00326

IPR2021-00528

PGR2019-00001

U.S. Patent Litigations

Case No(s):

0:15-cv-61631 (S.D. Fla.)

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

1:17-cv-00546 (D. Del.)

1:20-cv-00201 (D. Del.)

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

2:16-cv-01276 (D.N.J.)

2:17-cv-01235 (W.D. Pa.)

3:16-cv-02581 (N.D. Cal.)

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

56-2017-00493553-CU-BT-VTA (CA Sup. Ct.)

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