Purple Book reference family · 351(a) biologic
abciximab (Reopro)
abciximab is an FDA-licensed reference biologic from Janssen Biotech, Inc..
351(a) biologicBLA 103575 Janssen Biotech, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1994
Reference product
Originator biologic
351(a)BLA 103575
Reopro abciximab
Janssen Biotech, Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
RCSB Protein Data Bank
Experimental 3D structure for abciximab from the RCSB Protein Data Bank (PDB 6V4P).
Interactive biological assembly from PDB entry 6V4P. 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
Reference approval
Approval date of the reference abciximab product.
32 yr 2 mo ago
abciximab: 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 abciximab.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
