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FDA Purple Book · Reference family

von Willebrand factor (Recombinant) (Vonvendi)

von Willebrand factor (Recombinant) is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2015

Reference approved

Reference product

351(a)BLA 125577

Vonvendi von Willebrand factor (Recombinant)

Takeda Pharmaceuticals U.S.A., Inc.

Approved
Dec 08, 2015
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for von Willebrand factor (Recombinant), in chronological order.

  1. Reference approval

    Approval date of the reference von Willebrand factor (Recombinant) product.

    10 yr 8 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 2 yr 8 mo

Frequently asked questions

Are there biosimilars approved for von Willebrand factor (Recombinant) (Vonvendi)?

No 351(k) biosimilars or interchangeable biosimilars referencing von Willebrand factor (Recombinant) are listed in the FDA Purple Book yet.

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