Purple Book product · Reference 351(a)

Ruconest

C1 Esterase Inhibitor (Recombinant)

351(a)BLA 125495RxLicensed Pharming Americas BV

View C1 Esterase Inhibitor (Recombinant) family Label PDF Open on FDA Purple Book

Jul 16, 2014

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Ruconest (C1 Esterase Inhibitor (Recombinant)) is Pharming Americas BV's FDA-licensed reference biologic, approved under a 351(a) BLA in 2014. No biosimilars referencing Ruconest are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Jul 16, 2026.

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

Key dates

First licensure
Date the BLA was first licensed.
Jul 16, 2014
12 yr 2 mo ago
Approval
Approval date of this BLA submission.
Jul 16, 2014
12 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 16, 2021
5 yr 1 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Jul 16, 2026
2 d ago
Today

Pharmaceutical detail

Strength

2100IU

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

2079

Product number

001

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.

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

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

Frequently asked questions

Does Ruconest have approved biosimilars?

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

When does Ruconest lose reference-product exclusivity?

Ruconest's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Jul 16, 2026.

What is Ruconest's BLA number?

Ruconest is licensed under BLA 125495, held by Pharming Americas BV.

When was Ruconest approved by the FDA?

Ruconest was first licensed by the FDA on Jul 16, 2014.

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