Purple Book product · Reference 351(a)

Takhzyro

lanadelumab-flyo

351(a)BLA 761090RxLicensed Takeda Pharmaceuticals U.S.A., Inc.

View lanadelumab-flyo family Label PDF Open on FDA Purple Book

Feb 08, 2022

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Takhzyro (lanadelumab-flyo) is Takeda Pharmaceuticals U.S.A., Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2022. No biosimilars referencing Takhzyro 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 08, 2022
4 yr 6 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 03, 2030
in 3 yr 7 mo

Pharmaceutical detail

Strength

300MG/2ML (150MG/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1898

Product number

002

Submission type

Supplement

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.

2 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
monthly-downloadMonthly download · Jul 02, 2026

Change history

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

Frequently asked questions

Does Takhzyro have approved biosimilars?

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

What is Takhzyro's BLA number?

Takhzyro is licensed under BLA 761090, held by Takeda Pharmaceuticals U.S.A., Inc..

When was Takhzyro approved by the FDA?

Takhzyro was approved by the FDA on Feb 08, 2022.

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