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Purple Book reference family · 351(a) biologic

nirsevimab-alip (Beyfortus)

nirsevimab-alip is an FDA-licensed reference biologic from Sanofi Vaccines US Inc..

351(a) biologicBLA 761328 Sanofi Vaccines US Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023

Reference product

Originator biologic
351(a)BLA 761328

Beyfortus nirsevimab-alip

Sanofi Vaccines US Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for nirsevimab-alip from the RCSB Protein Data Bank (PDB 5UDC).

3D molecular structure of nirsevimab-alip (PDB entry 5UDC)

Interactive biological assembly from PDB entry 5UDC. 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 nirsevimab-alip product.

    3 yr 3 mo ago

nirsevimab-alip: 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 nirsevimab-alip.

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Agent CTA Background

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