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FDA Purple Book · Reference family

necitumumab (Portrazza)

necitumumab is an FDA-licensed reference biologic from Eli Lilly and Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2015

Reference approved

Reference product

351(a)BLA 125547

Portrazza necitumumab

Eli Lilly and Company

Approved
Nov 24, 2015
Marketing
Rx
Center
CDER
Patents
None listed

Molecular structure

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 — no need to leave the page.

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for necitumumab, in chronological order.

  1. Reference approval

    Approval date of the reference necitumumab product.

    10 yr 8 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    3 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for necitumumab (Portrazza)?

No 351(k) biosimilars or interchangeable biosimilars referencing necitumumab are listed in the FDA Purple Book yet.

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