FDA Purple Book · Reference family
sipuleucel-T (Provenge)
sipuleucel-T is an FDA-licensed reference biologic from Dendreon Pharmaceuticals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2010
Reference approved
Reference product
351(a)BLA 125197
Provenge sipuleucel-T
Dendreon Pharmaceuticals LLC
- Approved
- Apr 29, 2010
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for sipuleucel-T, in chronological order.
Reference approval
Approval date of the reference sipuleucel-T product.
16 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for sipuleucel-T (Provenge)?
No 351(k) biosimilars or interchangeable biosimilars referencing sipuleucel-T are listed in the FDA Purple Book yet.
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