laronidase (Aldurazyme)
laronidase 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
2003
Reference approved
Reference product
Aldurazyme laronidase
BioMarin Pharmaceutical Inc.
- Approved
- Apr 30, 2003
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for laronidase, in chronological order.
Reference approval
Approval date of the reference laronidase product.
23 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
16 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for laronidase (Aldurazyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing laronidase are listed in the FDA Purple Book yet.
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