FDA Purple Book · Reference family
insulin icodec-abae (Awiqli)
insulin icodec-abae is an FDA-licensed reference biologic from Novo Nordisk Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2026
Reference approved
Reference product
351(a)BLA 761326
Awiqli insulin icodec-abae
Novo Nordisk Inc.
- Approved
- Mar 26, 2026
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin icodec-abae, in chronological order.
Reference approval
Approval date of the reference insulin icodec-abae product.
2 mo ago
Frequently asked questions
Are there biosimilars approved for insulin icodec-abae (Awiqli)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin icodec-abae are listed in the FDA Purple Book yet.
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