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Darbepoetin alfa - Biologic Drug Details
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Summary for darbepoetin alfa
| Tradenames: | 1 |
| Patents: | 83 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for darbepoetin alfa |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for darbepoetin alfa |
Recent Clinical Trials for darbepoetin alfa
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Cadila Healthcare Limited | Phase 3 |
| Hospital Moinhos de Vento | Phase 3 |
| Akebia Therapeutics | Phase 1 |
Recent Litigation for darbepoetin alfa
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Ameranth, Inc. v. Starbucks Corporation | 2013-05-06 |
Pharmacology for darbepoetin alfa
| Ingredient-type | Erythropoietin |
| Physiological Effect | Increased Erythroid Cell Production |
Company Disclosures: US Patents for darbepoetin alfa
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 001 | 2001-09-17 | Start Trial | Kirin-Amgen, Inc. (Thousand Oaks, CA) | 2003-12-13 | RX | company | |
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 001 | 2001-09-17 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2024-05-15 | RX | company | |
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 002 | 2001-09-17 | Start Trial | Kirin-Amgen, Inc. (Thousand Oaks, CA) | 2003-12-13 | RX | company | |
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 002 | 2001-09-17 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2024-05-15 | RX | company | |
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 003 | 2001-09-17 | Start Trial | Kirin-Amgen, Inc. (Thousand Oaks, CA) | 2003-12-13 | RX | 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 darbepoetin alfa
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 001 | 2001-09-17 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2033-03-11 | RX | search | |
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 001 | 2001-09-17 | Start Trial | AMGEN INC. (Thousand Oaks, CA) | 2039-02-26 | RX | search | |
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 001 | 2001-09-17 | Start Trial | 2036-04-01 | RX | search | ||
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 001 | 2001-09-17 | Start Trial | YALE UNIVERSITY (New Haven, CT) | 2039-02-26 | RX | search | |
| Amgen | ARANESP | darbepoetin alfa | VIAL; INTRAVENOUS | 103951 | 001 | 2001-09-17 | Start Trial | GENOSCIENCE PHARMA (Marseilles, FR) | 2039-02-26 | RX | search | |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
International Patents for darbepoetin alfa
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2006231452 | Start Trial |
| Spain | 2389515 | Start Trial |
| Mexico | 2009004920 | Start Trial |
| China | 101815724 | Start Trial |
| Canada | 3045436 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for darbepoetin alfa
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 199059 | Germany | Start Trial | PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608 |
| 0075 | Netherlands | Start Trial | PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001 20010608 |
| /2001 | Austria | Start Trial | PRODUCT NAME: DARBEPOETIN-ALFA; REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608 |
| 43/2001 | Austria | Start Trial | PRODUCT NAME: DARBEPOETIN-ALFA |
| C028/2001 | Ireland | Start Trial | SPC028/2001: 20031204, EXPIRES: 20160607 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
