necitumumab (Portrazza)
necitumumab is an FDA-licensed reference biologic from Eli Lilly and Company. 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
Portrazza necitumumab
Eli Lilly and Company
- Approved
- Nov 24, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for necitumumab from the RCSB Protein Data Bank (PDB 6B3S).

Interactive biological assembly from PDB entry 6B3S. 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 necitumumab, in chronological order.
Reference approval
Approval date of the reference necitumumab product.
10 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for necitumumab (Portrazza)?
No 351(k) biosimilars or interchangeable biosimilars referencing necitumumab 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.
