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FDA Purple Book · Reference family

denileukin diftitox-cxdl (Lymphir)

denileukin diftitox-cxdl is an FDA-licensed reference biologic from Citius Oncology, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2024

Reference approved

Reference product

351(a)BLA 761312

Lymphir denileukin diftitox-cxdl

Citius Oncology, Inc.

Approved
Aug 07, 2024
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for denileukin diftitox-cxdl, in chronological order.

  1. Reference approval

    Approval date of the reference denileukin diftitox-cxdl product.

    1 yr 10 mo ago

Frequently asked questions

Are there biosimilars approved for denileukin diftitox-cxdl (Lymphir)?

No 351(k) biosimilars or interchangeable biosimilars referencing denileukin diftitox-cxdl are listed in the FDA Purple Book yet.

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