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Purple Book reference family · 351(a) biologic

insulin lispro (Admelog)

insulin lispro is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC.

351(a) biologicBLA 209196 Sanofi-Aventis U.S. LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018

Reference product

Originator biologic
351(a)BLA 209196

Admelog insulin lispro

Sanofi-Aventis U.S. LLC

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for insulin lispro from the RCSB Protein Data Bank (PDB 5UDP).

3D molecular structure of insulin lispro (PDB entry 5UDP)

Interactive biological assembly from PDB entry 5UDP. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference insulin lispro product.

    8 yr 1 mo ago

insulin lispro: 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 lispro.

Related FDA reference tools

Agent CTA Background

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