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Details for Biologics License Application: 103979
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Summary for BLA: 103979
| Tradename: | FABRAZYME |
| Applicant: | Genzyme |
| Ingredient: | agalsidase beta |
| Patents: | 21 |
| Approval Date: | Apr 24, 2003 |
| Suppliers: see list | 1 |
Pharmacology for BLA: 103979
| Ingredient-type | alpha-Glucosidases |
| Drug Class | Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme |
US Patents for BLA: 103979
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2033-03-11 | RX | search | |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | CureVac AG (Tubingen, DE) | 2032-02-15 | RX | search | |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | ALEXION PHARMACEUTICALS, INC. (New Haven, CT) | 2024-12-29 | RX | search | |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | Protalix Ltd. (Carmiel, IL) | 2029-11-17 | RX | search | |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
