Assyro AI
FDA Purple Book · Reference family

von Willebrand Factor/Coagulation Factor VIII Complex (Human) (Wilate)

von Willebrand Factor/Coagulation Factor VIII Complex (Human) is an FDA-licensed reference biologic from Octapharma Pharmazeutika Produktionsges.m.b.H.. 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 125251

Wilate von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Octapharma Pharmazeutika Produktionsges.m.b.H.

Approved
Dec 20, 2010
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for von Willebrand Factor/Coagulation Factor VIII Complex (Human), in chronological order.

  1. Reference approval

    Approval date of the reference von Willebrand Factor/Coagulation Factor VIII Complex (Human) product.

    15 yr 8 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 4 yr 7 mo

Frequently asked questions

Are there biosimilars approved for von Willebrand Factor/Coagulation Factor VIII Complex (Human) (Wilate)?

No 351(k) biosimilars or interchangeable biosimilars referencing von Willebrand Factor/Coagulation Factor VIII Complex (Human) are listed in the FDA Purple Book yet.

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

Open the Purple Book tool