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
Molecular structure
Experimental 3D structure for agalsidase beta from the RCSB Protein Data Bank (PDB 1R47).
Interactive biological assembly from PDB entry 1R47. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
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 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 8 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.