canakinumab (Ilaris)
canakinumab is an FDA-licensed reference biologic from Novartis Pharmaceuticals Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2009
Reference approved
Reference product
Ilaris canakinumab
Novartis Pharmaceuticals Corporation
- Approved
- Jun 17, 2009
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for canakinumab from the RCSB Protein Data Bank (PDB 4G5Z).
Interactive biological assembly from PDB entry 4G5Z. 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 canakinumab, in chronological order.
Reference approval
Approval date of the reference canakinumab product.
17 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 1 mo
Frequently asked questions
Are there biosimilars approved for canakinumab (Ilaris)?
No 351(k) biosimilars or interchangeable biosimilars referencing canakinumab 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.