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 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for FABRAZYME
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 2210947 | ⤷ Sign Up |
European Patent Office | 1020528 | ⤷ Sign Up |
Japan | 2004121260 | ⤷ Sign Up |
Portugal | 1942189 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FABRAZYME
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
122013000092 | Germany | ⤷ Sign Up | PRODUCT NAME: AGALSIDASE BETA; REGISTRATION NO/DATE: EU/1/01/188/001-006 20010803 |
SPC/GB13/069 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: AGALSIDASE BETA; REGISTERED: UK EU/1/01/188/001 20010807; UK EU/1/01/188/002 20010807; UK EU/1/01/188/003 20010807; UK EU/1/01/188/004 20010807; UK EU/1/01/188/005 20010807; UK EU/1/01/188/006 20010807 |
91703 | Luxembourg | ⤷ Sign Up | 91703, EXPIRES: 20160803 |
SZ 20/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: AGALSIDASE ALPHA |
>Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |