Purple Book product · Reference 351(a)

Trumenba

Meningococcal Group B Vaccine

351(a)BLA 125549RxLicensed Wyeth Pharmaceuticals LLC

View Meningococcal Group B Vaccine family Label PDF Open on FDA Purple Book

Oct 29, 2014

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Trumenba (Meningococcal Group B Vaccine) is Wyeth Pharmaceuticals LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2014. No biosimilars referencing Trumenba are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Oct 29, 2026.

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

Key dates

First licensure
Date the BLA was first licensed.
Oct 29, 2014
11 yr 11 mo ago
Approval
Approval date of this BLA submission.
Oct 29, 2014
11 yr 11 mo ago
Today
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Oct 29, 2026
in 3 mo

Pharmaceutical detail

Strength

0.5ML

Dosage form

Injection

Route

Intramuscular

Presentation

Pre-Filled Syringe

Center

CBER

License number

0003

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
monthly-downloadMonthly download · Jul 02, 2026

Change history

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

Frequently asked questions

Does Trumenba have approved biosimilars?

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

When does Trumenba lose reference-product exclusivity?

Trumenba's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Oct 29, 2026.

What is Trumenba's BLA number?

Trumenba is licensed under BLA 125549, held by Wyeth Pharmaceuticals LLC.

When was Trumenba approved by the FDA?

Trumenba was first licensed by the FDA on Oct 29, 2014.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo