Skip to content
Assyro AI
Purple Book reference family · 351(a) biologic

incobotulinumtoxinA (Xeomin)

incobotulinumtoxinA is an FDA-licensed reference biologic from Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC.

351(a) biologicBLA 125360 Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2015

Reference product

Originator biologic
351(a)BLA 125360

Xeomin incobotulinumtoxinA

Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for incobotulinumtoxinA from the RCSB Protein Data Bank (PDB 3BTA).

3D molecular structure of incobotulinumtoxinA (PDB entry 3BTA)

Interactive biological assembly from PDB entry 3BTA. 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 incobotulinumtoxinA product.

    11 yr ago

incobotulinumtoxinA: 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 incobotulinumtoxinA.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.