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PROLIA Drug Profile
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Summary for Tradename: PROLIA
| Patents: | 105 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Drug Prices: | Drug price information for PROLIA |
| Recent Clinical Trials: | See clinical trials for PROLIA |
Recent Clinical Trials for PROLIA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | Phase 2 |
| University of California, San Francisco | Phase 4 |
| San Francisco VA Health Care System | Phase 4 |
Pharmacology for PROLIA
| Mechanism of Action | RANK Ligand Blocking Activity |
Company Disclosures: US Patents for PROLIA
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Immunex Corporation (Seattle, WA) | 2016-12-23 | RX | Orphan | company |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2017-04-16 | RX | Orphan | company |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Amgen Inc. (Thousand Oaks, CA) Amgen Fremont Inc. (Fremont, CA) | 2021-06-26 | RX | Orphan | company |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Immunex Corporation (Thousand Oaks, CA) | 2016-12-23 | RX | Orphan | company |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Immunex Corporation (Thousand Oaks, CA) | 2016-12-23 | RX | Orphan | company |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Amgen Inc. (Thousand Oaks, CA) | 2017-04-16 | 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 PROLIA
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Fundacio Institut de Recerca Biomedica (IRB Barcelona) (Barcelona, ES) Institucio Catalana de Recerca I Estudis Avancats (Barcelona, ES) | 2039-02-26 | RX | Orphan | search |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2033-03-11 | RX | Orphan | search |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Fundacio Institut de Recerca Biomedica (IRB Barcelona) (Barcelona, ES) Institucio Catalana de Recerca I Estudis Avancats (Barcelona, ES) | 2030-10-06 | RX | Orphan | search |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | CONCIEVALVE, LLC (Minneapolis, MN) | 2032-10-22 | RX | Orphan | search |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | SUNSHINE LAKE PHARMA CO., LTD. (Dongguan, Guangdong, CN) | 2034-07-17 | RX | Orphan | search |
| Amgen | PROLIA | denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | 001 | 2010-06-01 | Start Trial | Celgene Corporation (Summit, NJ) | 2022-03-20 | 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 PROLIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 724828 | Start Trial |
| European Patent Office | 3524242 | Start Trial |
| New Zealand | 581637 | Start Trial |
| Hungary | E029682 | Start Trial |
| Portugal | 2223687 | Start Trial |
| Taiwan | 589376 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PROLIA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 1090038-9 | Sweden | Start Trial | PRODUCT NAME: DENOSUMAB |
| 2010/035 | Ireland | Start Trial | PRODUCT NAME: DENOSUMAB (PROLIA ); NAT REGISTRATION NO/DATE: EU/1/10/618/001 20100526; FIRST REGISTRATION NO/DATE: EU/1/10/618/002 26/05/2010 IRELAND EU/1/10/618/003 26/05/2010 IRELAND EU/1/10/618/004 26/05/2010 IRELAND EU/1/10/618/001 26/05/2010 IRELAND EU/1/10/618/002 26/05/2010 IRELAND EU/1/10/618/003 26/05/2010 IRELAND EU/1/10/618/004 20100526 |
| 10C0050 | France | Start Trial | PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100528 |
| 2010/034 | Ireland | Start Trial | PRODUCT NAME: DENOSUMAB (PROLIA ); NAT REGISTRATION NO/DATE: EU/1/10/618/001 20100526; FIRST REGISTRATION NO/DATE: EU/1/10/618/002 26/05/2010 IRELAND EU/1/10/618/003 26/05/2010 IRELAND EU/1/10/618/004 26/05/2010 IRELAND EU/1/10/618/001 26/05/2010 IRELAND EU/1/10/618/002 26/05/2010 IRELAND EU/1/10/618/003 26/05/2010 IRELAND EU/1/10/618/004 20100526 |
| C300465 | Netherlands | Start Trial | PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526 |
| 1990037-2 | Sweden | Start Trial | PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
