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FDA Purple Book · Reference family

Antihemophilic Factor (Recombinant), Full Length (Kovaltry)

Antihemophilic Factor (Recombinant), Full Length 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

2016

Reference approved

Reference product

351(a)BLA 125574

Kovaltry Antihemophilic Factor (Recombinant), Full Length

Bayer HealthCare LLC

Approved
Mar 16, 2016
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor (Recombinant), Full Length, in chronological order.

  1. Reference approval

    Approval date of the reference Antihemophilic Factor (Recombinant), Full Length product.

    10 yr 4 mo ago

Frequently asked questions

Are there biosimilars approved for Antihemophilic Factor (Recombinant), Full Length (Kovaltry)?

No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic Factor (Recombinant), Full Length are listed in the FDA Purple Book yet.

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