Purple Book reference family · 351(a) biologic
palifermin (Kepivance)
palifermin is an FDA-licensed reference biologic from Swedish Orphan Biovitrum AB (publ).
351(a) biologicBLA 125103 Swedish Orphan Biovitrum AB (publ)
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2004
Reference product
Originator biologic
351(a)BLA 125103
Kepivance palifermin
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 palifermin product.
21 yr 11 mo ago
palifermin: 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 palifermin.
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