Purple Book product · Reference 351(a)

prolastin,prolastin-c,prolastin-c liquid

Alpha-1-Proteinase Inhibitor (Human)

351(a)BLA 103174RxLicensed Grifols Therapeutics LLC

View Alpha-1-Proteinase Inhibitor (Human) family Label PDF Open on FDA Purple Book

Dec 02, 1987

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human)) is Grifols Therapeutics LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 1987. No biosimilars referencing prolastin,prolastin-c,prolastin-c 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.
Dec 02, 1987
39 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 02, 1994
32 yr 1 mo ago
Today

Pharmaceutical detail

Strength

1000MG

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1871

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.

4 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

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

Frequently asked questions

Does prolastin,prolastin-c,prolastin-c liquid have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing prolastin,prolastin-c,prolastin-c liquid are listed in the FDA Purple Book yet.

What is prolastin,prolastin-c,prolastin-c liquid's BLA number?

prolastin,prolastin-c,prolastin-c liquid is licensed under BLA 103174, held by Grifols Therapeutics LLC.

When was prolastin,prolastin-c,prolastin-c liquid approved by the FDA?

prolastin,prolastin-c,prolastin-c liquid was approved by the FDA on Dec 02, 1987.

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