ENBREL Drug Profile
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Summary for Tradename: ENBREL
High Confidence Patents: | 8 |
Applicants: | 1 |
BLAs: | 1 |
Drug Prices: | Drug price information for ENBREL |
Recent Clinical Trials: | See clinical trials for ENBREL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENBREL |
Recent Clinical Trials for ENBREL
Identify potential brand extensions & biosimilar entrants
Sponsor | Phase |
---|---|
Benaroya Research Institute | Early Phase 1 |
University of California, San Diego | Early Phase 1 |
Vanderbilt University | Phase 3 |
Recent Litigation for ENBREL
Identify key patents and potential future biosimilar entrants
District Court Litigation
Case Name | Date |
---|---|
AbbVie Inc. v. Hetero USA, Inc. | 2024-08-08 |
AbbVie Inc. v. Hetero USA, Inc. | 2023-11-20 |
FENNEC PHARMACEUTICALS, INC. v. CIPLA LIMITED | 2023-01-10 |
PTAB Litigation
Petitioner | Date |
---|---|
Dr. Reddy's Laboratories, Inc. | 2018-08-03 |
2014-11-06 | |
2013-08-15 |
Pharmacology for ENBREL
Mechanism of Action | Tumor Necrosis Factor Receptor Blocking Activity |
Established Pharmacologic Class | Tumor 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:
- Brand-side disclosures in response to biosimilar applications
- General brand-side disclosures
- Patents from broad patent text search
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.
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.
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 ENBREL Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for ENBREL Derived from Company Disclosures
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
---|---|---|---|---|---|---|---|
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | ⤷ Sign Up | 2036-10-21 | Company disclosures |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | ⤷ Sign Up | Company disclosures | |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | ⤷ Sign Up | 2012-03-07 | Company disclosures |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for ENBREL Derived from Patent Text Search
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
---|---|---|---|---|---|---|---|
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | ⤷ Sign Up | 2034-06-16 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | ⤷ Sign Up | 2033-08-13 | Patent claims search |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for ENBREL
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | H07508639 | ⤷ Sign Up |
European Patent Office | 0418014 | ⤷ Sign Up |
Australia | 4920993 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ENBREL
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
10075011 | Germany | ⤷ Sign Up | PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201 |
C300008 | Netherlands | ⤷ Sign Up | PRODUCT: ETANERCEPTUM |
0090011-8, 0091011-7 | Sweden | ⤷ Sign Up | NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201 |
>Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |