ENBREL Drug Profile
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Summary for Tradename: ENBREL
Recent Clinical Trials for ENBREL
Identify potential brand extensions & biosimilar entrants
Sponsor | Phase |
---|---|
University of California, San Diego | Early Phase 1 |
Benaroya Research Institute | Early Phase 1 |
Ottawa Hospital Research Institute | Phase 3 |
Recent Litigation for ENBREL
Identify key patents and potential future biosimilar entrants
District Court Litigation
Case Name | Date |
---|---|
AMGEN INC. v. APOTEX INC. | 2022-06-14 |
Pharmacyclics LLC v. Alvogen Pine Brook, LLC | 2020-03-20 |
Celgene Corporation v. Mylan Pharmaceuticals Inc. | 2020-01-02 |
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 | 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 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 | See Plans and Pricing | 2034-06-16 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | See Plans and Pricing | 2033-03-11 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | See Plans and Pricing | 2033-08-13 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | See Plans and Pricing | 2039-02-26 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | See Plans and Pricing | 2032-10-26 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | See Plans and Pricing | 2032-07-26 | Patent claims search |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | See Plans and Pricing | 2031-05-10 | 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 |
---|---|---|
Austria | 242322 | See Plans and Pricing |
Australia | 670125 | See Plans and Pricing |
South Africa | 907072 | See Plans and Pricing |
Finland | 20000833 | See Plans and Pricing |
South Korea | 950700937 | See Plans and Pricing |
European Patent Office | 0418014 | See Plans and Pricing |
Australia | 4920993 | See Plans and Pricing |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ENBREL
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
SPC/GB00/015 | United Kingdom | See Plans and Pricing | PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203 |
0090011-8, 0091011-7 | Sweden | See Plans and Pricing | NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201 |
132000900852970 | Italy | See Plans and Pricing | |
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 |
C300008 | Netherlands | See Plans and Pricing | PRODUCT: ETANERCEPTUM |
>Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |