FDA Purple Book · Reference family
palifermin (Kepivance)
palifermin is an FDA-licensed reference biologic from Swedish Orphan Biovitrum AB (publ). Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2004
Reference approved
Reference product
351(a)BLA 125103
Kepivance palifermin
Swedish Orphan Biovitrum AB (publ)
- Approved
- Dec 15, 2004
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for palifermin, in chronological order.
Reference approval
Approval date of the reference palifermin product.
21 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for palifermin (Kepivance)?
No 351(k) biosimilars or interchangeable biosimilars referencing palifermin are listed in the FDA Purple Book yet.
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