Pegfilgrastim - Biologic Drug Details

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Summary for pegfilgrastim

Tradenames:	2
High Confidence Patents:	22
Applicants:	9
BLAs:	9
Suppliers: see list	10
Recent Clinical Trials:	See clinical trials for pegfilgrastim
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pegfilgrastim

Recent Clinical Trials for pegfilgrastim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda	PHASE2
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1

See all pegfilgrastim clinical trials

Recent Litigation for pegfilgrastim

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
LIQUIDIA TECHNOLOGIES, INC. v. UNITED THERAPEUTICS CORPORATION	2025-04-21

See all pegfilgrastim litigation

Pharmacology for pegfilgrastim

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte 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. DrugPatentWatch analysis and 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 pegfilgrastim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegfilgrastim Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-12-20	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2035-10-19	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2035-11-20	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2035-04-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pegfilgrastim 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.	NEULASTA	pegfilgrastim	Injection	125031		2036-12-20	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-12-09	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2032-04-20	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031		2037-03-31	Patent claims search

International Patents for pegfilgrastim

Country	Patent Number	Estimated Expiration
Argentina	082615
Australia	2010249031
Australia	2010249033
Australia	2011252925

Supplementary Protection Certificates for pegfilgrastim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014C/003	Belgium		PRODUCT NAME: LIPEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/13/856 20130729
2014C/004	Belgium		PRODUCT NAME: LIPEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/13/856 20130725
CA 2014 00004	Denmark		PRODUCT NAME: LIPEGFILGRASTIM, HERUNDER METHOXYPOLYETHYLENGLYCOL KONJUGAT; REG. NO/DATE: EU/1/13/856 20130725
02C0048	France		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822