Purple Book product · Reference 351(a)

Mononine

Coagulation Factor IX (Human)

351(a)BLA 103957DiscVoluntarily Revoked CSL Behring LLC

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

Mar 17, 2000

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Mononine (Coagulation Factor IX (Human)) is CSL Behring LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2000. No biosimilars referencing Mononine 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.
Aug 20, 1999
27 yr 4 mo ago
Approval
Approval date of this BLA submission.
Mar 17, 2000
26 yr 9 mo ago
Today

Pharmaceutical detail

Strength

500IU

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1767

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.

1 additional BLA record 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
monthly-downloadMonthly download · Jul 02, 2026

Change history

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

Frequently asked questions

Does Mononine have approved biosimilars?

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

What is Mononine's BLA number?

Mononine is licensed under BLA 103957, held by CSL Behring LLC.

When was Mononine approved by the FDA?

Mononine was approved by the FDA on Mar 17, 2000.

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