Purple Book product · Reference 351(a)

Alphanine, Alphanine Hp, Alphanine Sd

Coagulation Factor IX (Human)

351(a)BLA 103249DiscLicensed Grifols Biologicals LLC

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

Dec 31, 1990

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human)) is Grifols Biologicals LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 1990. No biosimilars referencing Alphanine, Alphanine Hp, Alphanine Sd 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.
Dec 31, 1990
36 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 31, 1997
29 yr ago
Today

Pharmaceutical detail

Strength

250IU

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1694

Product number

003

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.

3 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 Alphanine, Alphanine Hp, Alphanine Sd have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Alphanine, Alphanine Hp, Alphanine Sd are listed in the FDA Purple Book yet.

What is Alphanine, Alphanine Hp, Alphanine Sd's BLA number?

Alphanine, Alphanine Hp, Alphanine Sd is licensed under BLA 103249, held by Grifols Biologicals LLC.

When was Alphanine, Alphanine Hp, Alphanine Sd approved by the FDA?

Alphanine, Alphanine Hp, Alphanine Sd was approved by the FDA on Dec 31, 1990.

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