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Purple Book reference family · 351(a) biologic

mecasermin (Increlex)

mecasermin is an FDA-licensed reference biologic from Eton Pharmaceuticals, Inc..

351(a) biologicBLA 021839 Eton Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2005

Reference product

Originator biologic
351(a)BLA 021839

Increlex mecasermin

Eton Pharmaceuticals, Inc.

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

Molecular structure

RCSB Protein Data Bank

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

3D molecular structure of mecasermin (PDB entry 1IMX)

Interactive biological assembly from PDB entry 1IMX. 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 mecasermin product.

    21 yr 4 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    14 yr 3 mo ago

mecasermin: 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 mecasermin.

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