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Last Updated: September 22, 2021

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Evolocumab - Biologic Drug Details


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Recent Clinical Trials for evolocumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Novo Nordisk A/SPhase 2
Duke UniversityEarly Phase 1
Beijing Anzhen HospitalPhase 3

See all evolocumab clinical trials

Recent Litigation for evolocumab

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Amgen Inc. v. Sanofi2017-01-11
Amgen Inc. v. Sanofi2014-11-16

See all evolocumab litigation

Pharmacology for evolocumab
Ingredient-typeAntibodies, Monoclonal
Mechanism of ActionPCSK9 Inhibitors
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 evolocumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for evolocumab Derived from Company Disclosures

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 Inc REPATHA evolocumab INJECTABLE;INJECTION 125522 001 2016-07-08 ⤷  Free Forever Trial Amgen, Inc. (Thousand Oaks, CA) 2027-08-23 RX Orphan company
Amgen Inc REPATHA evolocumab INJECTABLE;INJECTION 125522 001 2016-07-08 ⤷  Free Forever Trial Amgen Inc. (Thousand Oaks, CA) 2027-08-23 RX Orphan company
Amgen Inc REPATHA evolocumab INJECTABLE;INJECTION 125522 001 2016-07-08 ⤷  Free Forever Trial Amgen, Inc. (Thousand Oaks, CA) 2027-08-23 RX Orphan company
Amgen Inc REPATHA evolocumab INJECTABLE;INJECTION 125522 001 2016-07-08 ⤷  Free Forever Trial Amgen Inc. (Thousand Oaks, CA) 2027-08-23 RX Orphan company
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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

These patents were identified by searching patent claims

Supplementary Protection Certificates for evolocumab

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016025 Lithuania ⤷  Free Forever Trial PRODUCT NAME: ALIROKUMABAS; REGISTRATION NO/DATE: EU/1/15/1031 20150923
16010 Norway ⤷  Free Forever Trial PRODUCT NAME: EVOLOCUMAB; REG. NO/DATE: EU/1/15/1016 20150805
16/025 Ireland ⤷  Free Forever Trial PRODUCT NAME: EVOLOCUMAB; NAT REGISTRATION NO/DATE: EU/1/15/1016/001 - EU/1/15/1016/005 20150717;
0818 Netherlands ⤷  Free Forever Trial PRODUCT NAME: EVOLOCUMAB; REGISTRATION NO/DATE: EU/1/15/1016 20150721
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
McKinsey
Colorcon
Medtronic
Merck

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.