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Purple Book reference family · 351(a) biologic

Antithrombin (Recombinant) (Atryn)

Antithrombin (Recombinant) is an FDA-licensed reference biologic from rEVO Biologics, Inc..

351(a) biologicBLA 125284 rEVO Biologics, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2009

Reference product

Originator biologic
351(a)BLA 125284

Atryn Antithrombin (Recombinant)

rEVO Biologics, Inc.

View full reference-product record
Approved
Marketing
Disc
Center
CBER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for Antithrombin (Recombinant) from the RCSB Protein Data Bank (PDB 1E04).

3D molecular structure of Antithrombin (Recombinant) (PDB entry 1E04)

Interactive biological assembly from PDB entry 1E04. 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 Antithrombin (Recombinant) product.

    17 yr 11 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    10 yr 9 mo ago

Antithrombin (Recombinant): 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 Antithrombin (Recombinant).

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Agent CTA Background

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