Purple Book product · Reference 351(a)

VIMKUNYA

Chikungunya Vaccine, Recombinant

351(a)BLA 125820RxLicensed Bavarian Nordic A/S

View Chikungunya Vaccine, Recombinant family Label PDF Open on FDA Purple Book

Feb 14, 2025

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

VIMKUNYA (Chikungunya Vaccine, Recombinant) is Bavarian Nordic A/S's FDA-licensed reference biologic, approved under a 351(a) BLA in 2025. No biosimilars referencing VIMKUNYA are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Feb 14, 1937.

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).
Feb 14, 1937
90 yr 9 mo ago
First licensure
Date the BLA was first licensed.
Feb 14, 2025
1 yr 5 mo ago
Approval
Approval date of this BLA submission.
Feb 14, 2025
1 yr 5 mo ago
Today

Pharmaceutical detail

Strength

40UG/0.8ML

Dosage form

Injection

Route

Intramuscular

Presentation

Pre-Filled Syringe

Center

CBER

License number

2096

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 VIMKUNYA have approved biosimilars?

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

When does VIMKUNYA lose reference-product exclusivity?

VIMKUNYA's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Feb 14, 1937.

What is VIMKUNYA's BLA number?

VIMKUNYA is licensed under BLA 125820, held by Bavarian Nordic A/S.

When was VIMKUNYA approved by the FDA?

VIMKUNYA was first licensed by the FDA on Feb 14, 2025.

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