Purple Book product · Reference 351(a)

Benefix

Coagulation Factor IX (Recombinant)

351(a)BLA 103677RxLicensed Wyeth Pharmaceuticals LLC

View Coagulation Factor IX (Recombinant) family Label PDF Open on FDA Purple Book

Feb 11, 1997

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Benefix (Coagulation Factor IX (Recombinant)) is Wyeth Pharmaceuticals LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 1997. No biosimilars referencing Benefix 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.
Feb 11, 1997
29 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 11, 2004
22 yr 9 mo ago
Today

Pharmaceutical detail

Strength

500IU/ML

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

0003

Product number

002

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

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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 Benefix have approved biosimilars?

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

What is Benefix's BLA number?

Benefix is licensed under BLA 103677, held by Wyeth Pharmaceuticals LLC.

When was Benefix approved by the FDA?

Benefix was approved by the FDA on Feb 11, 1997.

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