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
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 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
14 yr 2 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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.