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Agalsidase beta - Biologic Drug Details

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Summary for agalsidase beta

Tradenames:	1
Patents:	26
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
Sanofi	Phase 4
University Hospital, Rouen	N/A
Amicus Therapeutics	Phase 2

See all agalsidase beta clinical trials

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:

1. Brand-side disclosures in response to biosimilar applications

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979		2039-02-26	Company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979		2033-03-11	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979		2032-02-15	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979		2024-12-29	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979		2029-11-17	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979		2028-06-26	Patent claims search

International Patents for agalsidase beta

Country	Patent Number	Estimated Expiration
Spain	2168101
Canada	2094922
Austria	464386
Sweden	2210947
European Patent Office	2210947

Supplementary Protection Certificates for agalsidase beta

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122013000092	Germany		PRODUCT NAME: AGALSIDASE BETA; REGISTRATION NO/DATE: EU/1/01/188/001-006 20010803
132013902212169	Italy		AUTHORISATION NUMBER(S) AND DATE(S): EU/1/01/188, 20010803;EU/1/01/188/001-002-003, 20010803
300452	Netherlands		PRODUCT NAME: AGALSIDASE ALFA; REGISTRATION NO/DATE: EU/1/01/189/001 20010807
CA 2010 00020	Denmark
SZ 20/2010	Austria		PRODUCT NAME: AGALSIDASE ALPHA