Purple Book reference family · 351(a) biologic
nivolumab and relatlimab-rmbw (Opdualag)
nivolumab and relatlimab-rmbw is an FDA-licensed reference biologic from Bristol-Myers Squibb Company.
351(a) biologicBLA 761234 Bristol-Myers Squibb Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2022
Reference product
Originator biologic
351(a)BLA 761234
Opdualag nivolumab and relatlimab-rmbw
Bristol-Myers Squibb Company
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference nivolumab and relatlimab-rmbw product.
4 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 6 mo
nivolumab and relatlimab-rmbw: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for nivolumab and relatlimab-rmbw.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
