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
Molecular structure
Experimental 3D structure for sebelipase alfa from the RCSB Protein Data Bank (PDB 6V7N).
Interactive biological assembly from PDB entry 6V7N. 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 sebelipase alfa, in chronological order.
Reference approval
Approval date of the reference sebelipase alfa product.
10 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 8 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.
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.