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Purple Book reference family · 351(a) biologic

denileukin diftitox-cxdl (Lymphir)

denileukin diftitox-cxdl is an FDA-licensed reference biologic from Citius Oncology, Inc..

351(a) biologicBLA 761312 Citius Oncology, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2024

Reference product

Originator biologic
351(a)BLA 761312

Lymphir denileukin diftitox-cxdl

Citius Oncology, 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 denileukin diftitox-cxdl product.

    2 yr ago

denileukin diftitox-cxdl: 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 denileukin diftitox-cxdl.

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Agent CTA Background

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