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Purple Book reference family · 351(a) biologic

Antithrombin III (Human) (Thrombate Iii)

Antithrombin III (Human) is an FDA-licensed reference biologic from Grifols Therapeutics LLC.

351(a) biologicBLA 103196 Grifols Therapeutics LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1991

Reference product

Originator biologic
351(a)BLA 103196

Thrombate Iii Antithrombin III (Human)

Grifols Therapeutics LLC

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

Molecular structure

RCSB Protein Data Bank

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

3D molecular structure of Antithrombin III (Human) (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 III (Human) product.

    35 yr 3 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 73 yr 4 mo

Antithrombin III (Human): 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 III (Human).

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