BLA number
125682
FDA Purple Book product · 351(a) biologic
Dengvaxia
Dengue Tetravalent Vaccine, Live
Dengvaxia, BLA 125682, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 1 exact FDA presentation row, and 0 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.
351(a)BLA 125682RxLicensed Sanofi Vaccines US Inc.
Approved
May 01, 2019
License type
351(a)
Marketing
Rx
Listed patents
0
Dengvaxia (Dengue Tetravalent Vaccine, Live) is Sanofi Vaccines US Inc.'s FDA-licensed 351(a) biologic under BLA 125682, approved in 2019. 0 distinct approved follow-on biologics explicitly reference Dengvaxia, making its reference-product role visible in the loaded family data. Its 12-year reference-product exclusivity under the BPCIA is listed as ending May 01, 2031.
Sourced from the FDA Purple Book · verified Aug 11, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(a) reference biologic
Applicant
Sanofi Vaccines US Inc.
Applicant is not automatically the physical manufacturer.
Presentations
1
Exact FDA presentation rows under this BLA.
Approval
May 01, 2019
Follow-on biologics
0
Dengvaxia is a 351(a) reference biologic supported by exact-BLA evidence.
0 distinct licensed follow-on biologics in the loaded Purple Book data name Dengvaxia as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.
Substitution boundary
Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.
Key dates
Licensure & exclusivity
First licensure
Date the BLA was first licensed.
May 01, 2019
7 yr 6 mo ago
Approval
Approval date of this BLA submission.
May 01, 2019
7 yr 6 mo ago
Today
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
May 01, 2031
in 4 yr 9 mo
Pharmaceutical detail
FDA product record
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
0
Change type
Not listed
Exact presentation matrix
One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50 | For Injection | Subcutaneous | Single-Dose Vial | Licensed | Rx |
Exact-source evidence coverage
Labeling & approval review
Current product label
Exact-source research required
No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.
FDA approval evidence
Not applicable to 351(a)
A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.
Human review pending
Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.
Reference product family
Biosimilars & interchangeables
0 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Dengvaxia; 0 are designated interchangeable and 0 have a licensed status in the loaded snapshot.
Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. No follow-on products are present in the loaded family snapshot.
Published patents
BPCIA 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.
Practical characteristics and limits
Source-bounded interpretation
Presentation coverage
1 exact FDA presentation row is consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Subcutaneous and For Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
Sanofi Vaccines US Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.
Regulatory comparison
Dengvaxia is a 351(a) reference biologic supported by exact-BLA evidence. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.
Source provenance
FDA Purple Book data
Source kind · Monthly download
Checked Aug 11, 2026FDA release · June 2026
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
What this record does not establish
- Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
- The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
- Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
- A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
- Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.
Change history
Record versions
- v4Aug 11, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Dengvaxia: frequently asked questions
Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.
Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
