Purple Book product · Reference 351(a)

Helixate Fs, Kogenate, Kogenate Fs

Antihemophilic Factor (Recombinant)

351(a)BLA 103332DiscVoluntarily Revoked Bayer HealthCare LLC

View Antihemophilic Factor (Recombinant) family Open on FDA Purple Book

Jun 07, 2007

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant)) is Bayer HealthCare LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2007. No biosimilars referencing Helixate Fs, Kogenate, Kogenate Fs are listed in the Purple Book yet.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 25, 2000
26 yr 9 mo ago
Approval
Approval date of this BLA submission.
Jun 07, 2007
19 yr 5 mo ago
Today

Pharmaceutical detail

Strength

2000IU

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

0008

Product number

004

Submission type

Supplement

Supplement number

5672

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 Helixate Fs, Kogenate, Kogenate Fs have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Helixate Fs, Kogenate, Kogenate Fs are listed in the FDA Purple Book yet.

What is Helixate Fs, Kogenate, Kogenate Fs's BLA number?

Helixate Fs, Kogenate, Kogenate Fs is licensed under BLA 103332, held by Bayer HealthCare LLC.

When was Helixate Fs, Kogenate, Kogenate Fs approved by the FDA?

Helixate Fs, Kogenate, Kogenate Fs was approved by the FDA on Jun 07, 2007.

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