Purple Book product · Reference 351(a)

Menquadfi

Meningococcal (Groups A, C, Y, W) Conjugate Vaccine

351(a)BLA 125701RxLicensed Sanofi Vaccines US Inc.

View Meningococcal (Groups A, C, Y, W) Conjugate Vaccine family Label PDF Open on FDA Purple Book

Apr 23, 2020

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Menquadfi (Meningococcal (Groups A, C, Y, W) Conjugate Vaccine) is Sanofi Vaccines US Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2020. No biosimilars referencing Menquadfi are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Apr 23, 1932.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Apr 23, 1932
95 yr 7 mo ago
First licensure
Date the BLA was first licensed.
Apr 23, 2020
6 yr 4 mo ago
Approval
Approval date of this BLA submission.
Apr 23, 2020
6 yr 4 mo ago
Today

Pharmaceutical detail

Strength

0.5ML

Dosage form

Injection

Route

Intramuscular

Presentation

Single-Dose Vial

Center

CBER

License number

1725

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

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Menquadfi have approved biosimilars?

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

When does Menquadfi lose reference-product exclusivity?

Menquadfi's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Apr 23, 1932.

What is Menquadfi's BLA number?

Menquadfi is licensed under BLA 125701, held by Sanofi Vaccines US Inc..

When was Menquadfi approved by the FDA?

Menquadfi was first licensed by the FDA on Apr 23, 2020.

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