cetuximab (Erbitux)
cetuximab is an FDA-licensed reference biologic from ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
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Biosimilars
0
Interchangeables
0
Listed patents
2004
Reference approved
Reference product
Erbitux cetuximab
ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company
- Approved
- Feb 12, 2004
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for cetuximab from the RCSB Protein Data Bank (PDB 1YY8).
Interactive biological assembly from PDB entry 1YY8. 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 cetuximab, in chronological order.
Reference approval
Approval date of the reference cetuximab product.
22 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
13 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for cetuximab (Erbitux)?
No 351(k) biosimilars or interchangeable biosimilars referencing cetuximab 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.