FDA Purple Book · Reference family
insulin lispro (Admelog)
insulin lispro is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
351(a)BLA 209196
Admelog insulin lispro
Sanofi-Aventis U.S. LLC
- Approved
- Oct 19, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin lispro, in chronological order.
Reference approval
Approval date of the reference insulin lispro product.
7 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for insulin lispro (Admelog)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin lispro are listed in the FDA Purple Book yet.
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