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Antihemophilic factor (recombinant), PEGylated-aucl (Jivi)

Antihemophilic factor (recombinant), PEGylated-aucl is an FDA-licensed reference biologic from Bayer HealthCare LLC. 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 125661

Jivi Antihemophilic factor (recombinant), PEGylated-aucl

Bayer HealthCare LLC

Approved
Aug 29, 2018
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Antihemophilic factor (recombinant), PEGylated-aucl, in chronological order.

  1. Reference approval

    Approval date of the reference Antihemophilic factor (recombinant), PEGylated-aucl product.

    7 yr 10 mo ago

Frequently asked questions

Are there biosimilars approved for Antihemophilic factor (recombinant), PEGylated-aucl (Jivi)?

No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic factor (recombinant), PEGylated-aucl are listed in the FDA Purple Book yet.

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