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Romiplostim - Biologic Drug Details
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Summary for romiplostim
| Tradenames: | 1 |
| Patents: | 24 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for romiplostim |
Recent Clinical Trials for romiplostim
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Seoul National University Hospital | Phase 2 |
| Peking Union Medical College Hospital | Phase 2/Phase 3 |
| Kyowa Hakko Kirin Korea Co., Ltd. | Phase 2 |
Pharmacology for romiplostim
| Mechanism of Action | Thrombopoietin Receptor Agonists |
| Physiological Effect | Increased Megakaryocyte Maturation Increased Platelet Production |
Company Disclosures: US Patents for romiplostim
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2018-10-23 | RX | Orphan | company |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2018-10-23 | RX | Orphan | company |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2018-10-23 | RX | Orphan | company |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2018-10-23 | 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 romiplostim
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | Glactone Pharma Development AB (Helsingborg, SE) | 2030-07-19 | RX | Orphan | search |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | Ohio University (Athens, OH) | 2030-03-24 | RX | Orphan | search |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | 2030-06-24 | RX | Orphan | search | |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | 2030-07-01 | RX | Orphan | search | |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2033-03-11 | RX | Orphan | search |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | Bayer Intellectual Property GmbH (Monheim, DE) | 2031-04-05 | RX | Orphan | search |
| Amgen | NPLATE | romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | 001 | 2008-08-22 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2029-05-13 | 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 romiplostim
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2016518879 | Start Trial |
| Hong Kong | 1042114 | Start Trial |
| Eurasian Patent Organization | 005404 | Start Trial |
| Denmark | 1144454 | Start Trial |
| Canada | 2347131 | Start Trial |
| Japan | 2006230413 | Start Trial |
| Australia | 1232200 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for romiplostim
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 6 | Finland | Start Trial | |
| 09/022 | Ireland | Start Trial | PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204 |
| 598 | Luxembourg | Start Trial | PRODUCT NAME: ROMIPLOSTIM (NPLATE - ROMIPLOSTIM) |
| /2009 | Austria | Start Trial | PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204 |
| 2009 00025 | Denmark | Start Trial | |
| 2009 009 | Romania | Start Trial | PRODUCT NAME: NPLATE-ROMIPLOSTIM; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/497/001, RO EU/1/08/497/002; DATE OF NATIONAL AUTHORISATION: 20090204; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/08/497/001, EMEA EU/1/08/497/002; DATE OF FIRST AUTHORISATION IN EEA: 20090204 |
| 1124961/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
