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FDA Purple Book · Reference family

moxetumomab pasudotox-tdfk (Lumoxiti)

moxetumomab pasudotox-tdfk is an FDA-licensed reference biologic from AstraZeneca AB. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2018

Reference approved

Reference product

351(a)BLA 761104

Lumoxiti moxetumomab pasudotox-tdfk

AstraZeneca AB

Approved
Sep 13, 2018
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for moxetumomab pasudotox-tdfk, in chronological order.

  1. Reference approval

    Approval date of the reference moxetumomab pasudotox-tdfk product.

    7 yr 10 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    9 mo ago

Frequently asked questions

Are there biosimilars approved for moxetumomab pasudotox-tdfk (Lumoxiti)?

No 351(k) biosimilars or interchangeable biosimilars referencing moxetumomab pasudotox-tdfk are listed in the FDA Purple Book yet.

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