Purple Book product · Reference 351(a)

Alphanate

Antihemophilic Factor/von Willebrand Factor Complex (Human)

351(a)BLA 102475RxLicensed Grifols Biologicals LLC

View Antihemophilic Factor/von Willebrand Factor Complex (Human) family Label PDF Open on FDA Purple Book

Aug 15, 1978

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human)) is Grifols Biologicals LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 1978. No biosimilars referencing Alphanate are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Aug 15, 1978
48 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jan 31, 2014
12 yr 8 mo ago
Today

Pharmaceutical detail

Strength

500IU

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1694

Product number

004

Submission type

Original

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

4 additional BLA records 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

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

v6Jul 02, 2026
v5Jul 02, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Alphanate have approved biosimilars?

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

What is Alphanate's BLA number?

Alphanate is licensed under BLA 102475, held by Grifols Biologicals LLC.

When was Alphanate approved by the FDA?

Alphanate was approved by the FDA on Aug 15, 1978.

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