Purple Book reference family · 351(a) biologic
nivolumab and hyaluronidase-nvhy (Opdivo Qvantig)
nivolumab and hyaluronidase-nvhy is an FDA-licensed reference biologic from Bristol-Myers Squibb Company.
351(a) biologicBLA 761381 Bristol-Myers Squibb Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 761381
Opdivo Qvantig nivolumab and hyaluronidase-nvhy
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 hyaluronidase-nvhy product.
8 mo ago
nivolumab and hyaluronidase-nvhy: 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 hyaluronidase-nvhy.
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