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FDA Purple Book · Reference family

abciximab (Reopro)

abciximab is an FDA-licensed reference biologic from Janssen Biotech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1994

Reference approved

Reference product

351(a)BLA 103575

Reopro abciximab

Janssen Biotech, Inc.

Approved
Dec 22, 1994
Marketing
Disc
Center
CDER
Patents
None listed

Molecular structure

Experimental 3D structure for abciximab from the RCSB Protein Data Bank (PDB 6V4P).

3D molecular structure of abciximab (PDB entry 6V4P)

Interactive biological assembly from PDB entry 6V4P. 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 abciximab, in chronological order.

  1. Reference approval

    Approval date of the reference abciximab product.

    31 yr 11 mo ago

Frequently asked questions

Are there biosimilars approved for abciximab (Reopro)?

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

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