Purple Book reference family · 351(a) biologic
emapalumab-lzsg (Gamifant)
emapalumab-lzsg is an FDA-licensed reference biologic from Swedish Orphan Biovitrum AB (publ).
351(a) biologicBLA 761107 Swedish Orphan Biovitrum AB (publ)
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 761107
Gamifant emapalumab-lzsg
Swedish Orphan Biovitrum AB (publ)
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 emapalumab-lzsg product.
3 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
10 mo ago
emapalumab-lzsg: 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 emapalumab-lzsg.
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