sebelipase alfa (Kanuma)
sebelipase alfa is an FDA-licensed reference biologic from Alexion Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Kanuma sebelipase alfa
Alexion Pharmaceuticals, Inc.
- Approved
- Dec 08, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for sebelipase alfa, in chronological order.
Reference approval
Approval date of the reference sebelipase alfa product.
10 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for sebelipase alfa (Kanuma)?
No 351(k) biosimilars or interchangeable biosimilars referencing sebelipase alfa are listed in the FDA Purple Book yet.
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