Agalsidase beta - Biologic Drug Details
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Summary for agalsidase beta
| Tradenames: | 1 |
| Patents: | 1 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for agalsidase beta |
Recent Clinical Trials for agalsidase beta
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Genzyme, a Sanofi Company | Phase 3 |
| Sanofi | Phase 4 |
| University Hospital, Rouen | N/A |
Pharmacology for agalsidase beta
| 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 agalsidase beta Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for agalsidase beta 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 | See Plans and Pricing | 2039-02-26 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for agalsidase beta 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 | See Plans and Pricing | 2033-03-11 | Patent claims search |
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | See Plans and Pricing | 2032-02-15 | Patent claims search |
| Genzyme Corporation | FABRAZYME | agalsidase beta | For Injection | 103979 | See Plans and Pricing | 2024-12-29 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for agalsidase beta
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1020528 | See Plans and Pricing |
| Portugal | 2210947 | See Plans and Pricing |
| European Patent Office | 2210947 | See Plans and Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for agalsidase beta
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C300627 | Netherlands | See Plans and Pricing | PRODUCT NAME: METHOD FOR PRODUCING SECRETED PROTIENS; REGISTRATION NO/DATE: EU/1/01/188/001-006 20010803 |
| 132010901851583 | Italy | See Plans and Pricing | |
| SPC/GB10/030 | United Kingdom | See Plans and Pricing | PRODUCT NAME: AGALSIDASE ALFA; REGISTERED: UK EU/1/01/189/001 20010807 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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