FABRAZYME Drug Profile
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Summary for Tradename: FABRAZYME
| High Confidence Patents: | 1 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for FABRAZYME |
Recent Clinical Trials for FABRAZYME
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Bio Sidus SA | Phase 3 |
| Sanofi | Phase 4 |
| Idorsia Pharmaceuticals Ltd. | Phase 1 |
Pharmacology for FABRAZYME
| Established Pharmacologic Class | Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme |
| Chemical Structure | alpha-Glucosidases |
Note on Biologic Patents
Matching patents to biologic drugs is far more complicated than for small-molecule drugs.
DrugPatentWatch employs three methods to identify biologic patents:
- Brand-side disclosures in response to biosimilar applications
- General brand-side disclosures
- Patents from broad patent text search
These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.
These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
1) High Certainty: US Patents for FABRAZYME Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for FABRAZYME Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | ⤷ Sign Up | 2039-02-26 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for FABRAZYME Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | ⤷ Sign Up | 2032-02-15 | Patent claims search |
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | ⤷ Sign Up | 2024-12-29 | Patent claims search |
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | ⤷ Sign Up | 2029-11-17 | Patent claims search |
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | ⤷ Sign Up | 2028-06-26 | Patent claims search |
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | ⤷ Sign Up | 2029-05-13 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for FABRAZYME
Supplementary Protection Certificates for FABRAZYME
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 132010901851583 | Italy | ⤷ Sign Up | |
| 300452 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AGALSIDASE ALFA; REGISTRATION NO/DATE: EU/1/01/189/001 20010807 |
| 10C0032 | France | ⤷ Sign Up | PRODUCT NAME: AGALSIDASE ALFA; NAT. REGISTRATION NO/DATE: EU/1/01/189/001-003 20010803; FIRST REGISTRATION: EU//1/01/189/001-003 20010803 |
| 2010/021 | Ireland | ⤷ Sign Up | PRODUCT NAME: AGALSIDASE ALFA; NAT REGISTRATION NO/DATE: EU/1/01/188/001-003 20010803; FIRST REGISTRATION NO/DATE: EU/1/01/189/001 03/08/2001 EUROPEAN UNION EU/1/01/188/001-003 03/08/2001 EUROPEAN UNION EU/1/01/189/001 20010803 |
| CA 2013 00060 | Denmark | ⤷ Sign Up | PRODUCT NAME: AGALSIDASE BETA; REG. NO/DATE: EU/1/01/188/001-003 20010803 |
| CA 2010 00020 | Denmark | ⤷ Sign Up | |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
