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Last Updated: May 25, 2022

Etanercept - Biologic Drug Details


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Recent Clinical Trials for etanercept

Identify potential brand extensions & biosimilar entrants

SponsorPhase
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Phase 1
Duke UniversityPhase 1
McGill University Health Centre/Research Institute of the McGill University Health CentreN/A

See all etanercept clinical trials

Recent Litigation for etanercept

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Pharmacyclics LLC v. Alvogen Pine Brook, LLC2020-03-20
Celgene Corporation v. Mylan Pharmaceuticals Inc.2020-01-02
CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC.2019-12-30

See all etanercept litigation

PTAB Litigation
PetitionerDate
Dr. Reddy's Laboratories, Inc.2018-08-03
2014-11-06
2013-08-15

See all etanercept litigation

Pharmacology for etanercept
Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic ClassTumor Necrosis Factor Blocker
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 etanercept Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Immunex Corporation ENBREL etanercept For Injection 103795 See Plans and Pricing 2012-03-07 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 See Plans and Pricing 2014-02-25 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 See Plans and Pricing 2009-09-05 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 See Plans and Pricing 2009-09-11 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 See Plans and Pricing 2009-09-05 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 See Plans and Pricing 2009-09-05 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 See Plans and Pricing 2019-04-19 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Supplementary Protection Certificates for etanercept

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0090011-8, 0091011-7 Sweden See Plans and Pricing NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
C300008 Netherlands See Plans and Pricing PRODUCT: ETANERCEPTUM
15/2000 Austria See Plans and Pricing PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
00C0015 France See Plans and Pricing PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI - IKS- N 55365 20000201
SZ 15/2000 Austria See Plans and Pricing PRODUCT NAME: ETANERCEPT
10075011 Germany See Plans and Pricing PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201
SPC/GB00/015 United Kingdom See Plans and Pricing PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203
>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.