nivolumab (Opdivo)
nivolumab is an FDA-licensed reference biologic from Bristol-Myers Squibb Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
Opdivo nivolumab
Bristol-Myers Squibb Company
- Approved
- Aug 27, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for nivolumab from the RCSB Protein Data Bank (PDB 5GGQ).
Interactive biological assembly from PDB entry 5GGQ. 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 nivolumab, in chronological order.
Reference approval
Approval date of the reference nivolumab product.
4 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 11 mo
Frequently asked questions
Are there biosimilars approved for nivolumab (Opdivo)?
No 351(k) biosimilars or interchangeable biosimilars referencing nivolumab 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.