FDA Purple Book · Reference family
nemolizumab-ilto (Nemluvio)
nemolizumab-ilto is an FDA-licensed reference biologic from Galderma Laboratories, L.P.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
351(a)BLA 761390
Nemluvio nemolizumab-ilto
Galderma Laboratories, L.P.
- Approved
- Aug 12, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for nemolizumab-ilto, in chronological order.
Reference approval
Approval date of the reference nemolizumab-ilto product.
1 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for nemolizumab-ilto (Nemluvio)?
No 351(k) biosimilars or interchangeable biosimilars referencing nemolizumab-ilto are listed in the FDA Purple Book yet.
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