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Romiplostim - Biologic Drug Details

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Summary for romiplostim

Tradenames:	1
Patents:	35
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for romiplostim

Recent Clinical Trials for romiplostim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
European Organisation for Research and Treatment of Cancer - EORTC	Phase 2
Dova Pharmaceuticals	Phase 4
David Gomez Almaguer	Phase 2

See all romiplostim clinical trials

Pharmacology for romiplostim

Mechanism of Action	Thrombopoietin Receptor Agonists
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production
Established Pharmacologic Class	Thrombopoietin Receptor Agonist

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 romiplostim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for romiplostim 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.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures

3) Low Certainty: US Patents for romiplostim 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.	NPLATE	romiplostim	For Injection	125268		2033-03-11	Patent claims search
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2034-11-21	Patent claims search
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2039-02-26	Patent claims search
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2031-04-05	Patent claims search
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2035-10-02	Patent claims search
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2039-12-21	Patent claims search
Amgen, Inc.	NPLATE	romiplostim	For Injection	125268		2029-05-13	Patent claims search

International Patents for romiplostim

Country	Patent Number	Estimated Expiration
New Zealand	528882
European Patent Office	1124961
Czech Republic	304242
Australia	2004200687
Cyprus	1114940
Slovenia	1783222
China	1908014

Supplementary Protection Certificates for romiplostim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C01124961/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
SZ 25/2009	Austria		PRODUCT NAME: ROMIPLOSTIM
91598	Luxembourg		PRODUCT NAME: ROMIPLOSTIM (NPLATE - ROMIPLOSTIM)
PA2009006,C1124961	Lithuania		PRODUCT NAME: ROMIPLOSTIMUM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204
346	Finland
09C0030	France		PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204
2009/022	Ireland		PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204