Purple Book product · Reference 351(a)

Gammagard Liquid

Immune Globulin Infusion (Human)

351(a)BLA 125105RxLicensed Takeda Pharmaceuticals U.S.A., Inc.

View Immune Globulin Infusion (Human) family Label PDF Open on FDA Purple Book

Apr 27, 2005

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Gammagard Liquid (Immune Globulin Infusion (Human)) is Takeda Pharmaceuticals U.S.A., Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2005. No biosimilars referencing Gammagard Liquid 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.
Apr 27, 2005
21 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 22, 2019
7 yr 2 mo ago
Today

Pharmaceutical detail

Strength

10% MG/ML

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Single-Use Bottle

Center

CBER

License number

1898

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
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Change history

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

Frequently asked questions

Does Gammagard Liquid have approved biosimilars?

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

What is Gammagard Liquid's BLA number?

Gammagard Liquid is licensed under BLA 125105, held by Takeda Pharmaceuticals U.S.A., Inc..

When was Gammagard Liquid approved by the FDA?

Gammagard Liquid was approved by the FDA on Apr 27, 2005.

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