Denosumab - Biologic Drug Details

Summary for denosumab

Tradenames:	2
High Confidence Patents:	10
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for denosumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for denosumab

Recent Clinical Trials for denosumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Peking Union Medical College Hospital	N/A
Aclaris Therapeutics, Inc.	Phase 1/Phase 2
Washington University School of Medicine	Phase 1/Phase 2

See all denosumab clinical trials

Recent Litigation for denosumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2018-04-30

See all denosumab litigation

Pharmacology for denosumab

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 denosumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

3) Low Certainty: US Patents for denosumab 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
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2034-07-17	Patent claims search
Amgen, Inc.	PROLIA	denosumab	Injection	125320		2022-03-20	Patent claims search

International Patents for denosumab

Country	Patent Number	Estimated Expiration
Australia	2013204100
European Patent Office	2311955
Norway	345566
Japan	2019214563
Spain	2144386
Austria	497001

Supplementary Protection Certificates for denosumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010C/038	Belgium		PRODUCT NAME: DENOSUMAB; AUTHORISATION NUMBER AND DATE: EU/1/10/618/001 20100528
C201000039	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
91757	Luxembourg		PRODUCT NAME: DENOSUMAB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (PROLIA ); AUTHORISATION NUMBER AND DATE: EU/1/10/618/001-004 20100528
132010901893989	Italy		PRODUCT NAME: DENOSUMAB(PROLIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/618/001-004, 20100526
2010C/037	Belgium		PRODUCT NAME: DENOSUMAB; AUTHORISATION NUMBER AND DATE: EU/1/10/618/001
C01409016/01	Switzerland		PRODUCT NAME: DENOSUMABUM; SWISSMEDIC-GESUCH 61865 12.07.2010; MAXIMALE LAUFZEIT: 02.02.2026