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FDA Purple Book · Reference family

concizumab-mtci (Alhemo)

concizumab-mtci is an FDA-licensed reference biologic from Novo Nordisk 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 761315

Alhemo concizumab-mtci

Novo Nordisk Inc.

Approved
Dec 20, 2024
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for concizumab-mtci, in chronological order.

  1. Reference approval

    Approval date of the reference concizumab-mtci product.

    1 yr 6 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 5 yr 8 mo

Frequently asked questions

Are there biosimilars approved for concizumab-mtci (Alhemo)?

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

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