XGEVA Drug Profile

Summary for Tradename: XGEVA

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for XGEVA

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 XGEVA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

3) Low Certainty: US Patents for XGEVA 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.	XGEVA	denosumab	Injection	125320		2039-02-26	Patent claims search
Amgen Inc.	XGEVA	denosumab	Injection	125320		2033-03-11	Patent claims search
Amgen Inc.	XGEVA	denosumab	Injection	125320		2030-10-06	Patent claims search
Amgen Inc.	XGEVA	denosumab	Injection	125320		2032-10-22	Patent claims search
Amgen Inc.	XGEVA	denosumab	Injection	125320		2034-07-17	Patent claims search

International Patents for XGEVA

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	199900939
European Patent Office	3492100
Slovenia	0975754
Israel	130492
Denmark	0946725

Supplementary Protection Certificates for XGEVA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010/036	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
SZ 45/2010	Austria		PRODUCT NAME: DENOSUMAB
132010901893988	Italy		PRODUCT NAME: DENOSUMAB(PROLIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/618/001-004, 20100526
122010000048	Germany		PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526
C01409016/01	Switzerland		PRODUCT NAME: DENOSUMABUM; SWISSMEDIC-GESUCH 61865 12.07.2010; MAXIMALE LAUFZEIT: 02.02.2026