Purple Book product · Reference 351(a)

Dengvaxia

Dengue Tetravalent Vaccine, Live

351(a)BLA 125682RxLicensed Sanofi Vaccines US Inc.

View Dengue Tetravalent Vaccine, Live family Label PDF Open on FDA Purple Book

May 01, 2019

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Dengvaxia (Dengue Tetravalent Vaccine, Live) is Sanofi Vaccines US Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2019. No biosimilars referencing Dengvaxia are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending May 01, 1931.

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).
May 01, 1931
96 yr 7 mo ago
First licensure
Date the BLA was first licensed.
May 01, 2019
7 yr 4 mo ago
Approval
Approval date of this BLA submission.
May 01, 2019
7 yr 4 mo ago
Today

Pharmaceutical detail

Strength

4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50

Dosage form

For Injection

Route

Subcutaneous

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 Dengvaxia have approved biosimilars?

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

When does Dengvaxia lose reference-product exclusivity?

Dengvaxia's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending May 01, 1931.

What is Dengvaxia's BLA number?

Dengvaxia is licensed under BLA 125682, held by Sanofi Vaccines US Inc..

When was Dengvaxia approved by the FDA?

Dengvaxia was first licensed by the FDA on May 01, 2019.

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