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Last Updated: June 30, 2022

PROLIA Drug Profile


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Summary for Tradename: PROLIA
Recent Clinical Trials for PROLIA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
mAbxience S.APhase 3
University of Texas Southwestern Medical CenterPhase 4
Gedeon Richter Plc.Phase 3

See all PROLIA clinical trials

Pharmacology for PROLIA
Mechanism of ActionRANK Ligand Blocking Activity
Established Pharmacologic ClassRANK 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 See Plans and Pricing 2016-12-23 Company disclosures
Amgen, Inc. PROLIA denosumab Injection 125320 See Plans and Pricing 2017-04-16 Company disclosures
Amgen, Inc. PROLIA denosumab Injection 125320 See Plans and Pricing 2021-06-26 Company disclosures
Amgen, Inc. PROLIA denosumab Injection 125320 See Plans and Pricing 2016-12-23 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for PROLIA Derived from Patent Text Search

These patents were obtained by searching patent claims

Supplementary Protection Certificates for PROLIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010/035 Ireland See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: DENOSUMAB; REG. NO/DATE: EU/1/10/618/001 20100526
300467 Netherlands See Plans and Pricing PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100528
C201000038 Spain See Plans and Pricing 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
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Johnson and Johnson
Moodys
Colorcon
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.