ansuvimab-zykl (Ebanga)
ansuvimab-zykl is an FDA-licensed reference biologic from Emergent Manufacturing Operations Baltimore LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2020
Reference approved
Reference product
Ebanga ansuvimab-zykl
Emergent Manufacturing Operations Baltimore LLC
- Approved
- Dec 21, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ansuvimab-zykl, in chronological order.
Reference approval
Approval date of the reference ansuvimab-zykl product.
5 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 7 mo
Frequently asked questions
Are there biosimilars approved for ansuvimab-zykl (Ebanga)?
No 351(k) biosimilars or interchangeable biosimilars referencing ansuvimab-zykl are listed in the FDA Purple Book yet.
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