galsulfase (Naglazyme)
galsulfase is an FDA-licensed reference biologic from BioMarin Pharmaceutical Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2005
Reference approved
Reference product
Naglazyme galsulfase
BioMarin Pharmaceutical Inc.
- Approved
- May 31, 2005
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for galsulfase from the RCSB Protein Data Bank (PDB 1FSU).
Interactive biological assembly from PDB entry 1FSU. 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 galsulfase, in chronological order.
Reference approval
Approval date of the reference galsulfase product.
21 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
14 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for galsulfase (Naglazyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing galsulfase 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.