Purple Book reference family · 351(a) biologic
donanemab-azbt (Kisunla)
donanemab-azbt is an FDA-licensed reference biologic from Eli Lilly and Company.
351(a) biologicBLA 761248 Eli Lilly and Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2024
Reference product
Originator biologic
351(a)BLA 761248
Kisunla donanemab-azbt
Eli Lilly and Company
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference donanemab-azbt product.
2 yr 1 mo ago
donanemab-azbt: 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 donanemab-azbt.
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