Dengue Tetravalent Vaccine, Live (Dengvaxia)
Dengue Tetravalent Vaccine, Live is an FDA-licensed reference biologic from Sanofi Pasteur 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 Pasteur 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.
First licensure
Date Dengue Tetravalent Vaccine, Live was first licensed by the FDA.
7 yr 2 mo ago
Reference approval
Approval date of the reference Dengue Tetravalent Vaccine, Live product.
7 yr 2 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 5 yr
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, 2031.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.