Purple Book reference family · 351(a) biologic
sipuleucel-T (Provenge)
sipuleucel-T is an FDA-licensed reference biologic from Dendreon Pharmaceuticals LLC.
351(a) biologicBLA 125197 Dendreon Pharmaceuticals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2010
Reference product
Originator biologic
351(a)BLA 125197
Provenge sipuleucel-T
Dendreon Pharmaceuticals LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference sipuleucel-T product.
16 yr 6 mo ago
sipuleucel-T: 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 sipuleucel-T.
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