Purple Book product · Reference 351(a)

Alprolix

Coagulation Factor IX (Recombinant), Fc Fusion Protein

351(a)BLA 125444RxLicensed Bioverativ Therapeutics, Inc.

View Coagulation Factor IX (Recombinant), Fc Fusion Protein family Label PDF Open on FDA Purple Book

Feb 18, 2016

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein) is Bioverativ Therapeutics, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2016. No biosimilars referencing Alprolix 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 18, 2016
10 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 28, 2021
5 yr 5 mo ago
Today

Pharmaceutical detail

Strength

250IU

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

2078

Product number

005

Submission type

Supplement

Supplement number

175

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.

5 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

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Alprolix have approved biosimilars?

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

What is Alprolix's BLA number?

Alprolix is licensed under BLA 125444, held by Bioverativ Therapeutics, Inc..

When was Alprolix approved by the FDA?

Alprolix was approved by the FDA on Feb 18, 2016.

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