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FDA Purple Book · Reference family

Albumin (Human)-kjda (Albuminex)

Albumin (Human)-kjda is an FDA-licensed reference biologic from Bio Products Laboratory Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2018

Reference approved

Reference product

351(a)BLA 125644

Albuminex Albumin (Human)-kjda

Bio Products Laboratory Limited

Approved
Jun 19, 2018
Marketing
Rx
Center
CBER
Patents
None listed

Molecular structure

Experimental 3D structure for Albumin (Human)-kjda from the RCSB Protein Data Bank (PDB 1AO6).

3D molecular structure of Albumin (Human)-kjda (PDB entry 1AO6)

Interactive biological assembly from PDB entry 1AO6. 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 Albumin (Human)-kjda, in chronological order.

  1. Reference approval

    Approval date of the reference Albumin (Human)-kjda product.

    8 yr 2 mo ago

Frequently asked questions

Are there biosimilars approved for Albumin (Human)-kjda (Albuminex)?

No 351(k) biosimilars or interchangeable biosimilars referencing Albumin (Human)-kjda are listed in the FDA Purple Book yet.

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