basiliximab (Simulect)
basiliximab 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
2003
Reference approved
Reference product
Simulect basiliximab
Novartis Pharmaceuticals Corporation
- Approved
- Jan 02, 2003
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for basiliximab from the RCSB Protein Data Bank (PDB 3IU3).
Interactive biological assembly from PDB entry 3IU3. 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 basiliximab, in chronological order.
Reference approval
Approval date of the reference basiliximab product.
23 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
21 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for basiliximab (Simulect)?
No 351(k) biosimilars or interchangeable biosimilars referencing basiliximab 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.