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Purple Book reference family · 351(a) biologic

ipilimumab (Yervoy)

ipilimumab is an FDA-licensed reference biologic from Bristol-Myers Squibb Company.

351(a) biologicBLA 125377 Bristol-Myers Squibb Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2011

Reference product

Originator biologic
351(a)BLA 125377

Yervoy ipilimumab

Bristol-Myers Squibb Company

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for ipilimumab from the RCSB Protein Data Bank (PDB 6RP8).

3D molecular structure of ipilimumab (PDB entry 6RP8)

Interactive biological assembly from PDB entry 6RP8. 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 ipilimumab product.

    15 yr 9 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 1 yr 1 mo

ipilimumab: 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 ipilimumab.

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Agent CTA Background

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