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FDA Purple Book · Reference family

sibeprenlimab-szsi (Voyxact)

sibeprenlimab-szsi is an FDA-licensed reference biologic from Otsuka Pharmaceutical Company, Ltd.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2025

Reference approved

Reference product

351(a)BLA 761434

Voyxact sibeprenlimab-szsi

Otsuka Pharmaceutical Company, Ltd.

Approved
Nov 25, 2025
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for sibeprenlimab-szsi, in chronological order.

  1. Reference approval

    Approval date of the reference sibeprenlimab-szsi product.

    6 mo ago

Frequently asked questions

Are there biosimilars approved for sibeprenlimab-szsi (Voyxact)?

No 351(k) biosimilars or interchangeable biosimilars referencing sibeprenlimab-szsi are listed in the FDA Purple Book yet.

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