Purple Book product · Reference 351(a)
Wilate
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Dec 20, 2010
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 01, 1930
97 yr ago
Approval
Approval date of this BLA submission.
Dec 20, 2010
15 yr 10 mo ago
Today
Pharmaceutical detail
Strength
500IU
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CBER
License number
1646
Product number
001
Submission type
Supplement
Supplement number
22
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
1 additional BLA record for this product (other strengths or presentations) are in the same reference family.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Wilate have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Wilate are listed in the FDA Purple Book yet.
What is Wilate's BLA number?
Wilate is licensed under BLA 125251, held by Octapharma Pharmazeutika Produktionsges.m.b.H..
When was Wilate approved by the FDA?
Wilate was approved by the FDA on Dec 20, 2010.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
