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Last Updated: February 20, 2020

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PROLIA Drug Profile


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Summary for Tradename: PROLIA
Recent Clinical Trials for PROLIA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
San Francisco VA Health Care SystemPhase 4
University of California, San FranciscoPhase 4
Qilu Pharmaceutical Co., Ltd.Phase 1

See all PROLIA clinical trials

Pharmacology for PROLIA
Mechanism of ActionRANK Ligand Blocking Activity

Company Disclosures: US Patents for PROLIA

These patents were extracted from company disclosures
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   Start Trial Immunex Corporation (Seattle, WA) 2016-12-23 RX Orphan company
Amgen PROLIA denosumab INJECTABLE; SUBCUTANEOUS 125320 001 2010-06-01   Start Trial Amgen Inc. (Thousand Oaks, CA) 2017-04-16 RX Orphan company
Amgen PROLIA denosumab INJECTABLE; SUBCUTANEOUS 125320 001 2010-06-01   Start Trial Amgen Inc. (Thousand Oaks, CA) Amgen Fremont Inc. (Fremont, CA) 2021-06-26 RX Orphan company
Amgen PROLIA denosumab INJECTABLE; SUBCUTANEOUS 125320 001 2010-06-01   Start Trial Immunex Corporation (Thousand Oaks, CA) 2016-12-23 RX Orphan company
Amgen PROLIA denosumab INJECTABLE; SUBCUTANEOUS 125320 001 2010-06-01   Start Trial Immunex Corporation (Thousand Oaks, CA) 2016-12-23 RX Orphan company
Amgen PROLIA denosumab INJECTABLE; SUBCUTANEOUS 125320 001 2010-06-01   Start Trial Amgen Inc. (Thousand Oaks, CA) 2017-04-16 RX Orphan company
Amgen PROLIA denosumab INJECTABLE; SUBCUTANEOUS 125320 001 2010-06-01   Start Trial Amgen Inc. (Thousand Oaks, CA) Amgen Fremont Inc. (Fremont, CA) 2021-06-26 RX Orphan company
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

Patent Text Search: US Patents for PROLIA

These patents were identified by searching patent claims

Supplementary Protection Certificates for PROLIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
122019000070 Germany   Start Trial PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
C01409016/01 Switzerland   Start Trial PRODUCT NAME: DENOSUMABUM; REGISTRATION NO/DATE: SWISSMEDIC 60210 03.08.2010
10C0050 France   Start Trial PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE IN FRANCE: EU/1/10/618/001 DU 20100526; REGISTRATION NO/DATE AT EEC: EU/1/10/618/001-004 DU 26-05-
1090037-1.L Sweden   Start Trial PRODUCT NAME: DENOSUMAB; REG. NO/DATE: EU/1/10/618/001 20100526
1090038-9.L Sweden   Start Trial PRODUCT NAME: DENOSUMAB; REG. NO/DATE: EU/1/10/618/001 20100526
132010901893988 Italy   Start Trial PRODUCT NAME: DENOSUMAB(PROLIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/618/001-004, 20100526
C300467 Netherlands   Start Trial PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
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Dow
Medtronic

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