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coagulation factor VIIa (recombinant)-jncw (Sevenfact)

coagulation factor VIIa (recombinant)-jncw is an FDA-licensed reference biologic from Laboratoire Francais du Fractionnement et des Biotechnologies S.A.. 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 125641

Sevenfact coagulation factor VIIa (recombinant)-jncw

Laboratoire Francais du Fractionnement et des Biotechnologies S.A.

Approved
Jun 20, 2024
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for coagulation factor VIIa (recombinant)-jncw, in chronological order.

  1. Reference approval

    Approval date of the reference coagulation factor VIIa (recombinant)-jncw product.

    2 yr ago

Frequently asked questions

Are there biosimilars approved for coagulation factor VIIa (recombinant)-jncw (Sevenfact)?

No 351(k) biosimilars or interchangeable biosimilars referencing coagulation factor VIIa (recombinant)-jncw are listed in the FDA Purple Book yet.

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