Pegfilgrastim - Biologic Drug Details

Summary for pegfilgrastim

Tradenames:	2
Patents:	3
Applicants:	5
BLAs:	5
Suppliers: see list	5
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
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Canadian Cancer Trials Group	Phase 3
Takeda	Phase 3

See all pegfilgrastim clinical trials

Pharmacology for pegfilgrastim

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 pegfilgrastim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegfilgrastim 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.	NEULASTA	pegfilgrastim	Injection	125031		2013-12-03	Company disclosures
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2013-12-10	Company disclosures
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2039-02-26	Company disclosures
Amgen, Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2013-12-03	Company disclosures
Amgen, Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2013-12-10	Company disclosures
Amgen, Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2039-02-26	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		2033-03-11	Patent claims search
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2021-05-01	Patent claims search
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-04-01	Patent claims search
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2039-02-26	Patent claims search
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-06-13	Patent claims search
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2031-04-05	Patent claims search
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031		2036-06-13	Patent claims search

International Patents for pegfilgrastim

Country	Patent Number	Estimated Expiration
Bulgaria	60170
China	1139932
Hong Kong	1008787
Hong Kong	71892
Spain	2001883
New Zealand	217334
Netherlands	300106

Supplementary Protection Certificates for pegfilgrastim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; NAT. REGISTRATION NO/DATE: EU/1/02/228/001 20020822; FIRST REGISTRATION: EU/1/02/228/001 20020822
SPC/GB14/009	United Kingdom		PRODUCT NAME: LIPEGFILGRASTIM; REGISTERED: UK EU/1/13/856/001 20130729
336 5002-2014	Slovakia		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130729
CA 2014 00004	Denmark		PRODUCT NAME: LIPEGFILGRASTIM, HERUNDER METHOXYPOLYETHYLENGLYCOL KONJUGAT; REG. NO/DATE: EU/1/13/856 20130725
4/2014	Austria		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
SZ 5/2003	Austria		PRODUCT NAME: PEGFILGRASTIM
5/2003	Austria		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822