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Details for Biologics License Application: 125486
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Summary for BLA: 125486
| Tradename: | GAZYVA |
| Applicant: | Genentech |
| Ingredient: | obinutuzumab |
| Patents: | 37 |
| Approval Date: | Nov 01, 2013 |
| Suppliers: see list | 1 |
Pharmacology for BLA: 125486
| Drug Class | CD20-directed Cytolytic Antibody |
| Mechanism of Action | CD20-directed Antibody Interactions |
US Patents for BLA: 125486
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech | GAZYVA | obinutuzumab | INJECTABLE;INJECTION | 125486 | 001 | 2013-11-01 | Start Trial | The United States of America, as represented by the Secretary, Department of Health and Human Services (Washington, DC) University of Virginia Patent Foundation (Charlottesville, VA) | 2034-01-08 | RX | Orphan | search |
| Genentech | GAZYVA | obinutuzumab | INJECTABLE;INJECTION | 125486 | 001 | 2013-11-01 | Start Trial | PRINCIPIA BIOPHARMA INC. (South San Francisco, CA) | 2034-02-21 | RX | Orphan | search |
| Genentech | GAZYVA | obinutuzumab | INJECTABLE;INJECTION | 125486 | 001 | 2013-11-01 | Start Trial | Celgene Corporation (Summit, NJ) | 2035-12-02 | RX | Orphan | search |
| Genentech | GAZYVA | obinutuzumab | INJECTABLE;INJECTION | 125486 | 001 | 2013-11-01 | Start Trial | Cipla Limited (Mumbai, IN) | 2036-06-30 | RX | Orphan | search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
