Dengue Tetravalent Vaccine, Live (Dengvaxia)
Dengue Tetravalent Vaccine, Live is an FDA-licensed reference biologic from Sanofi Vaccines US Inc..
Reference product
Dengvaxia Dengue Tetravalent Vaccine, Live
Sanofi Vaccines US Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
First licensure
Date Dengue Tetravalent Vaccine, Live was first licensed by the FDA.
7 yr 6 mo ago
Reference approval
Approval date of the reference Dengue Tetravalent Vaccine, Live product.
7 yr 6 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 4 yr 8 mo
Dengue Tetravalent Vaccine, Live: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Dengue Tetravalent Vaccine, Live.
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.
