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FDA Purple Book · Reference family

crizanlizumab-tmca (Adakveo)

crizanlizumab-tmca is an FDA-licensed reference biologic from Novartis Pharmaceuticals Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2019

Reference approved

Reference product

351(a)BLA 761128

Adakveo crizanlizumab-tmca

Novartis Pharmaceuticals Corporation

Approved
Nov 15, 2019
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for crizanlizumab-tmca, in chronological order.

  1. Reference approval

    Approval date of the reference crizanlizumab-tmca product.

    6 yr 8 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 6 mo

Frequently asked questions

Are there biosimilars approved for crizanlizumab-tmca (Adakveo)?

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

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