nivolumab and relatlimab-rmbw (Opdualag)
nivolumab and relatlimab-rmbw 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
2022
Reference approved
Reference product
Opdualag nivolumab and relatlimab-rmbw
Bristol-Myers Squibb Company
- Approved
- Mar 18, 2022
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for nivolumab and relatlimab-rmbw, in chronological order.
Reference approval
Approval date of the reference nivolumab and relatlimab-rmbw product.
4 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 10 mo
Frequently asked questions
Are there biosimilars approved for nivolumab and relatlimab-rmbw (Opdualag)?
No 351(k) biosimilars or interchangeable biosimilars referencing nivolumab and relatlimab-rmbw 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.