agalsidase beta (Fabrazyme)
agalsidase beta is an FDA-licensed reference biologic from Genzyme Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2003
Reference approved
Reference product
Fabrazyme agalsidase beta
Genzyme Corporation
- Approved
- Apr 24, 2003
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for agalsidase beta, in chronological order.
Reference approval
Approval date of the reference agalsidase beta product.
23 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 10 mo
Frequently asked questions
Are there biosimilars approved for agalsidase beta (Fabrazyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing agalsidase beta are listed in the FDA Purple Book yet.
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