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Agalsidase beta - Biologic Drug Details
Summary for agalsidase beta
| Tradenames: | 1 |
| Patents: | 17 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for agalsidase beta |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for agalsidase beta |
Recent Clinical Trials for agalsidase beta
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Sanofi | Phase 4 |
| University Hospital, Rouen | N/A |
| Amicus Therapeutics | Phase 2 |
Recent Litigation for agalsidase beta
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Shelbyzyme LLC v. Genzyme Corporation | 2009-10-14 |
Pharmacology for agalsidase beta
| Ingredient-type | alpha-Glucosidases |
Company Disclosures: US Patents for agalsidase beta
| 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 | Mount Sinai School of Medicine of the City of New York (New York, NY) | 2039-02-26 | RX | Orphan | company |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 002 | 2003-04-24 | Start Trial | Mount Sinai School of Medicine of the City of New York (New York, NY) | 2039-02-26 | 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 agalsidase beta
| 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 | Momenta Pharmaceuticals, Inc. (Cambridge, MA) | 2023-10-01 | RX | Orphan | search |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | Cell Therapeutics, Inc. (Seattle, WA) | 2025-01-25 | RX | Orphan | search |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | Protalix Ltd. (Carmiel, IL) | 2029-11-17 | RX | Orphan | search |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | Orphazyme Aps (Kobenhavn N, DK) | 2028-06-26 | RX | Orphan | search |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | Nanotech Biomachines, Inc. (Berkeley, CA) | 2033-07-12 | RX | Orphan | search |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | Nanotech Biomachines, Inc. (Berkeley, CA) | 2033-05-24 | RX | Orphan | search |
| Genzyme | FABRAZYME | agalsidase beta | VIAL; INTRAVENOUS | 103979 | 001 | 2003-04-24 | Start Trial | CureVac AG (Tubingen, DE) | 2032-02-15 | 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 agalsidase beta
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 235342 | Start Trial |
| Denmark | 2210947 | Start Trial |
| Israel | 200005 | Start Trial |
| Singapore | 10201606784Q | Start Trial |
| Singapore | 183558 | Start Trial |
| Australia | 2011222452 | Start Trial |
| Austria | 213020 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for agalsidase beta
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0064 | France | Start Trial | PRODUCT NAME: AGALSIDASE BETA; REGISTRATION NO/DATE: EU/1/01/188/001-006 20010807 |
| 2013000092 | Germany | Start Trial | PRODUCT NAME: AGALSIDASE BETA; REGISTRATION NO/DATE: EU/1/01/188/001-006 20010803 |
| 2013 00060 | Denmark | Start Trial | PRODUCT NAME: AGALSIDASE BETA; REG. NO/DATE: EU/1/01/188/001-003 20010803 |
| 1942189/01 | Switzerland | Start Trial | FORMER OWNER: MOUNT SINAI SCHOOL OF MEDICINE OF NEW YORK UNIVERSITY, US |
| C/GB10/030 | United Kingdom | Start Trial | PRODUCT NAME: AGALSIDASE ALFA; REGISTERED: UK EU/1/01/189/001 20010807 |
| 2010 00020 | Denmark | Start Trial | |
| 2010000028 | Germany | Start Trial | PRODUCT NAME: AGALSIDASE ALFA IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/01/189/001 20010803 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
