Neulasta® (pegfilgrastim)

BL 125031

Neulasta® (pegfilgrastim)

BL 125031

U.S. License Holder:

Amgen

Date of License:

January-31-2002

Last Update:

November-30-2018

approved_indications 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).

approved_indications aBLA / 505(b)(2) Activity


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

Fulphila (Mylan/Biocon) (June-2018) Udenyca (Coherus) (November-2018)

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

Lapelga: Apotex (December-2014) LA-EP2006: Sandoz (November-2015; Rejected Q2 2016)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Lapelga (Apotex) (April-2018)

Biosimilars Approved In The E.U.

Pelmeg (Cinfa Biotech / Mundipharma) (November-2018)
Ziextenzo® (Sandoz) (November-2018)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (Most Challenged Claims Unpatentable, 1 Claim Not Unpatentable); Request for Rehearing Pending

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.; ApoPharma USA, Inc.; Apotex Corp.; Apotex Holdings, Inc.; Apotex Inc.; Apotex Pharmaceutical Holdings Inc.; Intas Pharmaceuticals Ltd.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Awaiting Institution Decision

Final Written Decision Issued
Y

IPR Status
Challenges also include indefiniteness, written description, and enablement. Institution Decision Pending

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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

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.

Status
Case Ongoing

BPCIA
Y

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 Appeal Pending

BPCIA
Y

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

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

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
Case Ongoing

BPCIA
Y

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 Appeal Pending

BPCIA
Y

U.S. Patent Nos.
[None Listed]

Plaintiffs
Amgen Inc.

Defendants
Coherus Biosciences Inc.

Status
Case Ongoing

BPCIA
N

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Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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