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FDA Purple Book · Reference family

donislecel-jujn (Lantidra)

donislecel-jujn is an FDA-licensed reference biologic from CellTrans Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2023

Reference approved

Reference product

351(a)BLA 125734

Lantidra donislecel-jujn

CellTrans Inc.

Approved
Jun 28, 2023
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for donislecel-jujn, in chronological order.

  1. Reference approval

    Approval date of the reference donislecel-jujn product.

    3 yr ago

Frequently asked questions

Are there biosimilars approved for donislecel-jujn (Lantidra)?

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

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