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Last Updated: January 30, 2023

Denosumab - Biologic Drug Details


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Summary for denosumab
Tradenames:2
Patents:10
Applicants:1
BLAs:1
Suppliers: see list1
Recent Clinical Trials: See clinical trials for denosumab
Recent Clinical Trials for denosumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Dong-A ST Co., Ltd.Phase 4
The Affiliated Hospital of Qingdao UniversityPhase 4
Aristotle University Of ThessalonikiPhase 4

See all denosumab clinical trials

Pharmacology for denosumab
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 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 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
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 denosumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Supplementary Protection Certificates for denosumab

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
CA 2010 00032 Denmark See Plans and Pricing PRODUCT NAME: DENOSUMAB
SZ 44/2010 Austria See Plans and Pricing PRODUCT NAME: DENOSUMAB
C00951551/01 Switzerland See Plans and Pricing PRODUCT NAME: DENOSUMABUM; REGISTRATION NO/DATE: SWISSMEDIC 60210 03.08.2010
2010C/037 Belgium See Plans and Pricing PRODUCT NAME: DENOSUMAB; AUTHORISATION NUMBER AND DATE: EU/1/10/618/001
122010000047 Germany See Plans and Pricing 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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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.