Neulasta® — Venable's BiologicsHQ

U.S. License Holder:

Amgen

Date of License:

January-31-2002

Last Update:

Dec-15-2024

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) Pelgraz: Accord (Submission Date Undisclosed)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Armlupeg® (Lupin) (August-2024)
Fulphila® (Mylan) (May-2019)
Lapelga (Apotex) (April-2018)
Niopeg® (Nora Pharma) (April-2024)
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

Filpelga® (Cipla) (August-2022)
Fulphila® (Alphapharm / Mylan / Biocon) (August-2018)
Neutropeg® (Accord Healthcare) (August-2019)
Pelgraz® (Accord Healthcare) (December-2019)
Ziextenzo® (Sandoz) (September-2019)

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

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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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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