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Purple Book reference family · 351(a) biologic

dostarlimab-gxly (Jemperli)

dostarlimab-gxly is an FDA-licensed reference biologic from GlaxoSmithKline LLC.

351(a) biologicBLA 761174 GlaxoSmithKline LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2021

Reference product

Originator biologic
351(a)BLA 761174

Jemperli dostarlimab-gxly

GlaxoSmithKline LLC

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for dostarlimab-gxly from the RCSB Protein Data Bank (PDB 7WSL).

3D molecular structure of dostarlimab-gxly (PDB entry 7WSL)

Interactive biological assembly from PDB entry 7WSL. 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 dostarlimab-gxly product.

    5 yr 6 mo ago

dostarlimab-gxly: 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 dostarlimab-gxly.

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Agent CTA Background

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