Purple Book reference family · 351(a) biologic
insulin icodec-abae (Awiqli)
insulin icodec-abae is an FDA-licensed reference biologic from Novo Nordisk Inc..
351(a) biologicBLA 761326 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 761326
Awiqli insulin icodec-abae
Novo Nordisk Inc.
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 insulin icodec-abae product.
4 mo ago
insulin icodec-abae: 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 insulin icodec-abae.
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