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Purple Book reference family · 351(a) biologic

necitumumab (Portrazza)

necitumumab is an FDA-licensed reference biologic from Eli Lilly and Company.

351(a) biologicBLA 125547 Eli Lilly and Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2015

Reference product

Originator biologic
351(a)BLA 125547

Portrazza necitumumab

Eli Lilly and Company

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for necitumumab from the RCSB Protein Data Bank (PDB 6B3S).

3D molecular structure of necitumumab (PDB entry 6B3S)

Interactive biological assembly from PDB entry 6B3S. 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 necitumumab product.

    11 yr ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    3 yr 11 mo ago

necitumumab: 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 necitumumab.

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Agent CTA Background

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