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Etanercept - Biologic Drug Details
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Summary for etanercept
| Tradenames: | 1 |
| Patents: | 378 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 2 |
| Recent Clinical Trials: | See clinical trials for etanercept |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for etanercept |
Recent Clinical Trials for etanercept
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Phase 1 |
| Duke University | Phase 1 |
| Anelixis Therapeutics, Inc. | Phase 2 |
Recent Litigation for etanercept
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Celgene Corporation v. Mylan Pharmaceuticals Inc. | 2020-01-02 |
| CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. | 2019-12-30 |
| CELGENE CORPORATION v. HETERO LABS LIMITED | 2019-07-16 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Dr. Reddy's Laboratories, Inc. | 2018-08-03 |
| 2014-11-06 | |
| 2013-08-15 |
Pharmacology for etanercept
| Mechanism of Action | Tumor Necrosis Factor Receptor Blocking Activity |
Company Disclosures: US Patents for etanercept
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Immunex Corporation (Seattle, WA) | 2012-03-07 | RX | Orphan | company |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Immunex Corporation (Seattle, WA) | 2014-02-25 | RX | Orphan | company |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Immunex Corporation (Seattle, WA) | 2009-09-05 | RX | Orphan | company |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Immunex Corporation (Seattle, WA) | 2009-09-11 | RX | Orphan | company |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | 2009-09-05 | RX | Orphan | company | |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Immunex Corporation (Seattle, WA) | 2009-09-05 | RX | Orphan | company |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
Patent Text Search: US Patents for etanercept
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Massachusetts Eye and Ear Infirmary (Boston, MA) | 2034-06-16 | RX | Orphan | search |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2033-03-11 | RX | Orphan | search |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Knopp Biosciences LLC (Pittsburgh, PA) | 2033-08-13 | RX | Orphan | search |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | Coherus Biosciences, Inc. (Redwood City, CA) | 2039-02-26 | RX | Orphan | search |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | LUPIN LIMITED (Mumbai, Maharashtra, IN) | 2032-10-26 | RX | Orphan | search |
| Immunex | ENBREL | etanercept | VIAL; SUBCUTANEOUS | 103795 | 001 | 1998-11-02 | Start Trial | The William M. Yarbrough foundation (Peoria, IL) | 2032-07-26 | RX | Orphan | search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
International Patents for etanercept
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2015028087 | Start Trial |
| Canada | 2478731 | Start Trial |
| Australia | 2015258859 | Start Trial |
| Denmark | 2295081 | Start Trial |
| Germany | 602004017608 | Start Trial |
| Canada | 2436659 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for etanercept
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017 00012 | Denmark | Start Trial | PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707 |
| 2015 016 | Romania | Start Trial | PRODUCT NAME: IBRUTINIB SAU O SARE FARMACEUTIC ACCEPTABILA A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/945; DATE OF NATIONAL AUTHORISATION: 20141021; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/945; DATE OF FIRST AUTHORISATION IN EEA: 20141021 |
| 01930044 | Spain | Start Trial | PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
| 19C/008 | Belgium | Start Trial | PRODUCT NAME: APREMILAST,OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116 |
| 2017 00061 | Denmark | Start Trial | PRODUCT NAME: SARILUMAB; REG. NO/DATE: EU/1/17/1196/001-8 20170627 |
| 1 | Finland | Start Trial | |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
