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Last Updated: September 22, 2021

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FABRAZYME Drug Profile


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UNDER DEVELOPMENT

When do Fabrazyme patents expire, and when can biosimilar versions of Fabrazyme launch?

Fabrazyme is a drug marketed by Genzyme and is included in one BLA.

The biologic ingredient in FABRAZYME is agalsidase beta. A full profile is posted on the agalsidase beta profile page.

DrugPatentWatch® Biosimilar and Interchangeable Outlook for Fabrazyme

Indicators of Biosimilar Launch

Under Development

  Free Forever Trial

Summary for Tradename: FABRAZYME
Patents:26
Applicants:1
BLAs:1
Suppliers: see list1
Recent Clinical Trials: See clinical trials for FABRAZYME
Recent Clinical Trials for FABRAZYME

Identify potential brand extensions & biosimilar entrants

SponsorPhase
SanofiPhase 4
ActelionPhase 1
University of Alabama at BirminghamN/A

See all FABRAZYME clinical trials

Pharmacology for FABRAZYME
Ingredient-typealpha-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:

  1. Brand-side disclosures in response to biosimilar applications
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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

These patents were extracted from company disclosures
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 ⤷  Free Forever 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 ⤷  Free Forever 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

3) Low Certainty: US Patents for FABRAZYME Derived from Patent Text Search

These patents were identified by searching patent claims

Supplementary Protection Certificates for FABRAZYME

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
SPC/GB10/030 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: AGALSIDASE ALFA; REGISTERED: UK EU/1/01/189/001 20010807
122010000028 Germany ⤷  Free Forever Trial PRODUCT NAME: AGALSIDASE ALFA IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/01/189/001 20010803
20/2010 Austria ⤷  Free Forever Trial PRODUCT NAME: AGALSIDASE ALPHA; REGISTRATION NO/DATE: EU/1/01/189/001 20010803
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Baxter
Merck
Medtronic
Boehringer Ingelheim

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.