Purple Book product · Reference 351(a)

Hympavzi

marstacimab-hncq

351(a)BLA 761369RxLicensed Pfizer Inc.

View marstacimab-hncq family Label PDF Open on FDA Purple Book

Jun 05, 2026

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Hympavzi (marstacimab-hncq) is Pfizer Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2026. No biosimilars referencing Hympavzi 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.
Jun 05, 2026
1 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Oct 11, 2031
in 5 yr 4 mo

Pharmaceutical detail

Strength

75MG/0.5ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

2001

Product number

003

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.

3 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

v7Jul 02, 2026
v6Jul 02, 2026
v5Jul 02, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026
v1Jul 02, 2026

Frequently asked questions

Does Hympavzi have approved biosimilars?

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

What is Hympavzi's BLA number?

Hympavzi is licensed under BLA 761369, held by Pfizer Inc..

When was Hympavzi approved by the FDA?

Hympavzi was approved by the FDA on Jun 05, 2026.

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