Dengue Tetravalent Vaccine, Live (Dengvaxia)
Dengue Tetravalent Vaccine, Live is an FDA-licensed reference biologic from Sanofi Vaccines US Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Dengvaxia Dengue Tetravalent Vaccine, Live
Sanofi Vaccines US Inc.
- Approved
- May 01, 2019
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Dengue Tetravalent Vaccine, Live, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
96 yr 7 mo ago
First licensure
Date Dengue Tetravalent Vaccine, Live was first licensed by the FDA.
7 yr 4 mo ago
Reference approval
Approval date of the reference Dengue Tetravalent Vaccine, Live product.
7 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for Dengue Tetravalent Vaccine, Live (Dengvaxia)?
No 351(k) biosimilars or interchangeable biosimilars referencing Dengue Tetravalent Vaccine, Live are listed in the FDA Purple Book yet.
When does Dengue Tetravalent Vaccine, Live (Dengvaxia) lose reference-product exclusivity?
Dengue Tetravalent Vaccine, Live's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending May 1, 1931.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.