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Purple Book reference family · 351(a) biologic

vestronidase alfa-vjbk (Mepsevii)

vestronidase alfa-vjbk is an FDA-licensed reference biologic from Ultragenyx Pharamceutical Inc..

351(a) biologicBLA 761047 Ultragenyx Pharamceutical Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017

Reference product

Originator biologic
351(a)BLA 761047

Mepsevii vestronidase alfa-vjbk

Ultragenyx Pharamceutical Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for vestronidase alfa-vjbk from the RCSB Protein Data Bank (PDB 1BHG).

3D molecular structure of vestronidase alfa-vjbk (PDB entry 1BHG)

Interactive biological assembly from PDB entry 1BHG. 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 vestronidase alfa-vjbk product.

    9 yr ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    1 yr 11 mo ago

vestronidase alfa-vjbk: 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 vestronidase alfa-vjbk.

Related FDA reference tools

Agent CTA Background

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