Ebola Zaire Vaccine, Live (Ervebo)
Ebola Zaire Vaccine, Live is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. 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
Ervebo Ebola Zaire Vaccine, Live
Merck Sharp & Dohme LLC
- Approved
- Dec 19, 2019
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Ebola Zaire Vaccine, Live, in chronological order.
First licensure
Date Ebola Zaire Vaccine, Live was first licensed by the FDA.
6 yr 7 mo ago
Reference approval
Approval date of the reference Ebola Zaire Vaccine, Live product.
6 yr 7 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 5 yr 8 mo
Frequently asked questions
Are there biosimilars approved for Ebola Zaire Vaccine, Live (Ervebo)?
No 351(k) biosimilars or interchangeable biosimilars referencing Ebola Zaire Vaccine, Live are listed in the FDA Purple Book yet.
When does Ebola Zaire Vaccine, Live (Ervebo) lose reference-product exclusivity?
Ebola Zaire Vaccine, Live's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending December 19, 2031.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.