Purple Book product · Reference 351(a)
Ervebo
Ebola Zaire Vaccine, Live
Dec 19, 2019
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Dec 19, 1931
96 yr ago
First licensure
Date the BLA was first licensed.
Dec 19, 2019
6 yr 8 mo ago
Approval
Approval date of this BLA submission.
Dec 19, 2019
6 yr 8 mo ago
Today
Pharmaceutical detail
Strength
1ML
Dosage form
Injection
Route
Intramuscular
Presentation
Single-Dose Vial
Center
CBER
License number
0002
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Ervebo have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Ervebo are listed in the FDA Purple Book yet.
When does Ervebo lose reference-product exclusivity?
Ervebo's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Dec 19, 1931.
What is Ervebo's BLA number?
Ervebo is licensed under BLA 125690, held by Merck Sharp & Dohme LLC.
When was Ervebo approved by the FDA?
Ervebo was first licensed by the FDA on Dec 19, 2019.
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.
