FDA Purple Book · Reference family
donanemab-azbt (Kisunla)
donanemab-azbt is an FDA-licensed reference biologic from Eli Lilly and Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
351(a)BLA 761248
Kisunla donanemab-azbt
Eli Lilly and Company
- Approved
- Jul 02, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for donanemab-azbt, in chronological order.
Reference approval
Approval date of the reference donanemab-azbt product.
1 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for donanemab-azbt (Kisunla)?
No 351(k) biosimilars or interchangeable biosimilars referencing donanemab-azbt are listed in the FDA Purple Book yet.
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