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Purple Book reference family · 351(a) biologic

insulin detemir (Levemir)

insulin detemir is an FDA-licensed reference biologic from Novo Nordisk Inc..

351(a) biologicBLA 021536 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2005

Reference product

Originator biologic
351(a)BLA 021536

Levemir insulin detemir

Novo Nordisk Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for insulin detemir from the RCSB Protein Data Bank (PDB 8IPZ).

3D molecular structure of insulin detemir (PDB entry 8IPZ)

Interactive biological assembly from PDB entry 8IPZ. 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 detemir product.

    21 yr 7 mo ago

insulin detemir: 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 detemir.

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Agent CTA Background

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