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FDA Purple Book · Reference family

linvoseltamab-gcpt (Lynozyfic)

linvoseltamab-gcpt is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2025

Reference approved

Reference product

351(a)BLA 761400

Lynozyfic linvoseltamab-gcpt

Regeneron Pharmaceuticals, Inc.

Approved
Jul 02, 2025
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for linvoseltamab-gcpt, in chronological order.

  1. Reference approval

    Approval date of the reference linvoseltamab-gcpt product.

    11 mo ago

Frequently asked questions

Are there biosimilars approved for linvoseltamab-gcpt (Lynozyfic)?

No 351(k) biosimilars or interchangeable biosimilars referencing linvoseltamab-gcpt are listed in the FDA Purple Book yet.

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