Purple Book product · Reference 351(a)

CAPVAXIVE

Pneumococcal 21-valent Conjugate Vaccine

351(a)BLA 125814RxLicensed Merck Sharp & Dohme LLC

View Pneumococcal 21-valent Conjugate Vaccine family Label PDF Open on FDA Purple Book

Jun 17, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) is Merck Sharp & Dohme LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing CAPVAXIVE are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Jun 17, 1936.

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 17, 1936
91 yr 5 mo ago
First licensure
Date the BLA was first licensed.
Jun 17, 2024
2 yr 1 mo ago
Approval
Approval date of this BLA submission.
Jun 17, 2024
2 yr 1 mo ago
Today

Pharmaceutical detail

Strength

84UG/.5ML

Dosage form

Injection

Route

Intramuscular

Presentation

Pre-Filled Syringe

Center

CBER

License number

0002

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 CAPVAXIVE have approved biosimilars?

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

When does CAPVAXIVE lose reference-product exclusivity?

CAPVAXIVE's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Jun 17, 1936.

What is CAPVAXIVE's BLA number?

CAPVAXIVE is licensed under BLA 125814, held by Merck Sharp & Dohme LLC.

When was CAPVAXIVE approved by the FDA?

CAPVAXIVE was first licensed by the FDA on Jun 17, 2024.

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