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Etanercept - Biologic Drug Details
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See Plans and PricingSummary for etanercept
| Tradenames: | 1 |
| Patents: | 343 |
| 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 |
|---|---|
| Nanfang Hospital of Southern Medical University | Phase 4 |
| Lawson Health Research Institute | Phase 4 |
| Academic Medical Organization of Southwestern Ontario | Phase 4 |
Recent Litigation for etanercept
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. | 2019-12-31 |
| CELGENE CORPORATION v. HETERO LABS LIMITED | 2019-07-16 |
| CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD. | 2019-07-12 |
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 |
| >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 |
| >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 |
|---|---|---|
| European Patent Office | 1631266 | Start Trial |
| Japan | 2017002068 | Start Trial |
| China | 100427085 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for etanercept
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2041177/01 | Switzerland | Start Trial | PRODUCT NAME: SARILUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66424 20.04.2018 |
| 17/056 | Ireland | Start Trial | PRODUCT NAME: SARILUMAB; REGISTRATION NO/DATE: EU/1/17/1196 20170623 |
| 00728 | Netherlands | Start Trial | PRODUCT NAME: IBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
