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Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (Advate)

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2003

Reference approved

Reference product

351(a)BLA 125063

Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method

Takeda Pharmaceuticals U.S.A., Inc.

Approved
Jul 25, 2003
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method, in chronological order.

  1. Reference approval

    Approval date of the reference Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method product.

    23 yr 2 mo ago

Frequently asked questions

Are there biosimilars approved for Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (Advate)?

No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method are listed in the FDA Purple Book yet.

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