PROLIA Drug Profile

Summary for Tradename: PROLIA

Patents:	10
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PROLIA
Recent Clinical Trials:	See clinical trials for PROLIA

See drug prices for PROLIA

Recent Clinical Trials for PROLIA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
mAbxience S.A	Phase 3
University of Texas Southwestern Medical Center	Phase 4
Gedeon Richter Plc.	Phase 3

See all PROLIA clinical trials

Pharmacology for PROLIA

Mechanism of Action	RANK Ligand Blocking Activity
Established Pharmacologic Class	RANK Ligand Inhibitor

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 PROLIA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PROLIA 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.	PROLIA	denosumab	Injection	125320		2016-12-23	Company disclosures
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2017-04-16	Company disclosures
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2021-06-26	Company disclosures
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2016-12-23	Company disclosures

3) Low Certainty: US Patents for PROLIA 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.	PROLIA	denosumab	Injection	125320		2039-02-26	Patent claims search
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2033-03-11	Patent claims search
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2030-10-06	Patent claims search
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2032-10-22	Patent claims search

International Patents for PROLIA

Country	Patent Number	Estimated Expiration
New Zealand	547695
Australia	2011202547
Denmark	0951551
Spain	2675735

Supplementary Protection Certificates for PROLIA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010/035	Ireland		PRODUCT NAME: DENOSUMAB (PROLIA ); NAT REGISTRATION NO/DATE: EU/1/10/618/001 20100526; FIRST REGISTRATION NO/DATE: EU/1/10/618/002 26/05/2010 IRELAND EU/1/10/618/003 26/05/2010 IRELAND EU/1/10/618/004 26/05/2010 IRELAND EU/1/10/618/001 26/05/2010 IRELAND EU/1/10/618/002 26/05/2010 IRELAND EU/1/10/618/003 26/05/2010 IRELAND EU/1/10/618/004 20100526
1090038-9.L	Sweden		PRODUCT NAME: DENOSUMAB; REG. NO/DATE: EU/1/10/618/001 20100526
300467	Netherlands		PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100528
C201000038	Spain		PRODUCT NAME: DENOSUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/10/618/001-004; DATE OF AUTHORISATION: 20100526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/618/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20100526