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Purple Book reference family · 351(a) biologic

linvoseltamab-gcpt (Lynozyfic)

linvoseltamab-gcpt is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc..

351(a) biologicBLA 761400 Regeneron Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025

Reference product

Originator biologic
351(a)BLA 761400

Lynozyfic linvoseltamab-gcpt

Regeneron Pharmaceuticals, Inc.

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

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference linvoseltamab-gcpt product.

    1 yr 1 mo ago

linvoseltamab-gcpt: 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 linvoseltamab-gcpt.

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Agent CTA Background

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