Purple Book reference family · 351(a) biologic
Ebola Zaire Vaccine, Live (Ervebo)
Ebola Zaire Vaccine, Live is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.
351(a) biologicBLA 125690 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 125690
Ervebo Ebola Zaire Vaccine, Live
Merck Sharp & Dohme LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
First licensure
Date Ebola Zaire Vaccine, Live was first licensed by the FDA.
6 yr 10 mo ago
Reference approval
Approval date of the reference Ebola Zaire Vaccine, Live product.
6 yr 10 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 5 yr 4 mo
Ebola Zaire 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 Ebola Zaire Vaccine, Live.
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