idursulfase (Elaprase)
idursulfase is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2006
Reference approved
Reference product
Elaprase idursulfase
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Jul 24, 2006
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for idursulfase, in chronological order.
Reference approval
Approval date of the reference idursulfase product.
20 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
13 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for idursulfase (Elaprase)?
No 351(k) biosimilars or interchangeable biosimilars referencing idursulfase are listed in the FDA Purple Book yet.
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