Purple Book reference family · 351(a) biologic
sibeprenlimab-szsi (Voyxact)
sibeprenlimab-szsi is an FDA-licensed reference biologic from Otsuka Pharmaceutical Company, Ltd..
351(a) biologicBLA 761434 Otsuka Pharmaceutical Company, Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 761434
Voyxact sibeprenlimab-szsi
Otsuka Pharmaceutical Company, Ltd.
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 sibeprenlimab-szsi product.
8 mo ago
sibeprenlimab-szsi: 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 sibeprenlimab-szsi.
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