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Purple Book reference family · 351(a) biologic

somatropin (Accretropin)

somatropin is an FDA-licensed reference biologic from Emergent Biosolutions Canada Inc..

351(a) biologicBLA 021538 Emergent Biosolutions Canada Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2008

Reference product

Originator biologic
351(a)BLA 021538

Accretropin somatropin

Emergent Biosolutions Canada Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for somatropin from the RCSB Protein Data Bank (PDB 1HGU).

3D molecular structure of somatropin (PDB entry 1HGU)

Interactive biological assembly from PDB entry 1HGU. 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 somatropin product.

    18 yr 11 mo ago

somatropin: 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 somatropin.

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