Purple Book product · Reference 351(a)

Prevnar 20

Pneumococcal 20-valent Conjugate Vaccine

351(a)BLA 125731RxLicensed Wyeth Pharmaceuticals LLC

View Pneumococcal 20-valent Conjugate Vaccine family Label PDF Open on FDA Purple Book

Jun 08, 2021

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) is Wyeth Pharmaceuticals LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2021. No biosimilars referencing Prevnar 20 are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Jun 08, 1933.

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).
Jun 08, 1933
94 yr 6 mo ago
First licensure
Date the BLA was first licensed.
Jun 08, 2021
5 yr 2 mo ago
Approval
Approval date of this BLA submission.
Jun 08, 2021
5 yr 2 mo ago
Today

Pharmaceutical detail

Strength

0.5 ML

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 Prevnar 20 have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Prevnar 20 are listed in the FDA Purple Book yet.

When does Prevnar 20 lose reference-product exclusivity?

Prevnar 20's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Jun 08, 1933.

What is Prevnar 20's BLA number?

Prevnar 20 is licensed under BLA 125731, held by Wyeth Pharmaceuticals LLC.

When was Prevnar 20 approved by the FDA?

Prevnar 20 was first licensed by the FDA on Jun 08, 2021.

Related FDA reference tools

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

Book a Demo