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Purple Book reference family · 351(a) biologic

rimabotulinumtoxinB (Myobloc)

rimabotulinumtoxinB is an FDA-licensed reference biologic from Solstice NeuroSciences, LLC.

351(a) biologicBLA 103846 Solstice NeuroSciences, LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000

Reference product

Originator biologic
351(a)BLA 103846

Myobloc rimabotulinumtoxinB

Solstice NeuroSciences, LLC

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for rimabotulinumtoxinB from the RCSB Protein Data Bank (PDB 1S0B).

3D molecular structure of rimabotulinumtoxinB (PDB entry 1S0B)

Interactive biological assembly from PDB entry 1S0B. 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 rimabotulinumtoxinB product.

    26 yr 2 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    19 yr 1 mo ago

rimabotulinumtoxinB: 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 rimabotulinumtoxinB.

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