Filgrastim - Biologic Drug Details

Summary for filgrastim

Tradenames:	1
High Confidence Patents:	5
Applicants:	4
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for filgrastim
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for filgrastim

Recent Clinical Trials for filgrastim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Newlife Fertility Centre	Phase 4
National Cancer Center, Korea	Phase 2
Seoul National University Hospital	Phase 2

See all filgrastim clinical trials

Recent Litigation for filgrastim

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Pandora Marketing LLC	2024-01-31
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all filgrastim litigation

PTAB Litigation

Petitioner	Date
	2016-09-15
	2012-09-25

See all filgrastim litigation

Pharmacology for filgrastim

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor Granulocyte-Macrophage Colony-Stimulating Factor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for filgrastim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for filgrastim Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353		2006-03-07	Company disclosures
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353			Company disclosures
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353			Company disclosures
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353		2013-12-03	Company disclosures

3) Low Certainty: US Patents for filgrastim Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353		2033-03-11	Patent claims search
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353		2039-02-26	Patent claims search
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353		2034-11-21	Patent claims search
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353		2034-04-01	Patent claims search

International Patents for filgrastim

Country	Patent Number	Estimated Expiration
Japan	2660179
Austria	E63758
Norway	20032250
European Patent Office	1018552

Supplementary Protection Certificates for filgrastim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB03/006	United Kingdom		PRODUCT NAME: PEGFILGRASTIM, AN N-TERMINALLY MONOPEGYLATED G-CSF (GRANULOCYTE COLONY STIMULATING FACTOR); REGISTERED: UK EU/1/02/228/001 20020826; UK EU/1/02/227/001 20020826
SPC/GB14/009	United Kingdom		PRODUCT NAME: LIPEGFILGRASTIM; REGISTERED: UK EU/1/13/856/001 20130729
C 2014 004	Romania		PRODUCT NAME: LIPEGFILGRASTIM; NATIONAL AUTHORISATION NUMBER: EU/1/13/856; DATE OF NATIONAL AUTHORISATION: 20130725; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/856; DATE OF FIRST AUTHORISATION IN EEA: 20130725
CA 2014 00004	Denmark		PRODUCT NAME: LIPEGFILGRASTIM, HERUNDER METHOXYPOLYETHYLENGLYCOL KONJUGAT; REG. NO/DATE: EU/1/13/856 20130725