Agalsidase beta - Biologic Drug Details

Summary for agalsidase beta

Tradenames:	1
High Confidence 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
ISU Abxis Co., Ltd.	Phase 3
Bio Sidus SA	Phase 3
Genzyme, a Sanofi Company	Phase 3

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
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979		2029-05-13	Patent claims search

International Patents for agalsidase beta

Country	Patent Number	Estimated Expiration
Sweden	2210947
World Intellectual Property Organization (WIPO)	9207936
Israel	200005
Canada	2094922
Germany	122010000028
Germany	69133263

Supplementary Protection Certificates for agalsidase beta

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132010901851583	Italy
300452	Netherlands		PRODUCT NAME: AGALSIDASE ALFA; REGISTRATION NO/DATE: EU/1/01/189/001 20010807
10C0032	France		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		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		PRODUCT NAME: AGALSIDASE BETA; REG. NO/DATE: EU/1/01/188/001-003 20010803
CA 2010 00020	Denmark