Purple Book product · Reference 351(a)

Krystexxa

pegloticase

351(a)BLA 125293RxLicensed Horizon Therapeutics Ireland DAC

View pegloticase family Label PDF Open on FDA Purple Book

Sep 14, 2010

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Krystexxa (pegloticase) is Horizon Therapeutics Ireland DAC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2010. No biosimilars referencing Krystexxa 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.
Sep 14, 2010
16 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Sep 14, 2017
9 yr ago
Today

Pharmaceutical detail

Strength

8MG/ML

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

2022

Product number

001

Submission type

Original

Supplement number

Not listed

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

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Change history

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

Frequently asked questions

Does Krystexxa have approved biosimilars?

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

What is Krystexxa's BLA number?

Krystexxa is licensed under BLA 125293, held by Horizon Therapeutics Ireland DAC.

When was Krystexxa approved by the FDA?

Krystexxa was approved by the FDA on Sep 14, 2010.

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