Romiplostim - Biologic Drug Details

Summary for romiplostim

Tradenames:	1
Patents:	4
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
Peking University People's Hospital	Phase 2
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Phase 3
Geropharm	Phase 1

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

International Patents for romiplostim

Country	Patent Number	Estimated Expiration
Mexico	PA01003873
World Intellectual Property Organization (WIPO)	0024782
China	1331701
Slovakia	4962001
Japan	2007105044
World Intellectual Property Organization (WIPO)	0024770

Supplementary Protection Certificates for romiplostim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 25/2009	Austria		PRODUCT NAME: ROMIPLOSTIM
CA 2009 00025	Denmark
C200900026	Spain		PRODUCT NAME: ROMIPLOSTIM; NATIONAL AUTHORISATION NUMBER: 1/08/497/001-002; DATE OF AUTHORISATION: 20090204; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UEEU/1/08/497/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20090204
PA2009006	Lithuania		PRODUCT NAME: ROMIPLOSTIMUM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204
SPC/GB09/035	United Kingdom		PRODUCT NAME: ROMIPLOSTIM; REGISTERED: UK EU/1/08/497/001 20090206; UK EU/1/08/497/002 20090206
25/2009	Austria		PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204