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Last Updated: September 22, 2021

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Details for Biologics License Application: 125320

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Summary for BLA: 125320

Tradename:	XGEVA
Applicant:	Amgen
Ingredient:	denosumab
Patents:	129
Approval Date:	Jun 01, 2010
Suppliers: see list	1

Pharmacology for BLA: 125320

Drug Class	RANK Ligand Inhibitor
Mechanism of Action	RANK Ligand Blocking Activity

US Patents for BLA: 125320

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Number	Approval Date	Patent No.	Assignee	Estimated Patent Expiration	Status	Orphan	Source
Amgen	PROLIA	denosumab	INJECTABLE; SUBCUTANEOUS	125320	001	2010-06-01	⤷ Free Forever Trial	Fundacio Institut de Recerca Biomedica (IRB Barcelona) (Barcelona, ES) Institucio Catalana de Recerca I Estudis Avancats (Barcelona, ES)	2039-02-26	RX	Orphan	search
Amgen	PROLIA	denosumab	INJECTABLE; SUBCUTANEOUS	125320	001	2010-06-01	⤷ Free Forever Trial	SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL)	2033-03-11	RX	Orphan	search
Amgen	PROLIA	denosumab	INJECTABLE; SUBCUTANEOUS	125320	001	2010-06-01	⤷ Free Forever Trial	Fundacio Institut de Recerca Biomedica (IRB Barcelona) (Barcelona, ES) Institucio Catalana de Recerca I Estudis Avancats (Barcelona, ES)	2030-10-06	RX	Orphan	search
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Number	>Approval Date	>Patent No.	>Assignee	>Estimated Patent Expiration	>Status	>Orphan	>Source

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Serving leading biopharmaceutical companies globally:

Medtronic

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