Assyro AI
FDA Purple Book · Reference family

Antihemophilic Factor (Recombinant) (Bioclate (Armour), Recombinate)

Antihemophilic Factor (Recombinant) 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

2010

Reference approved

Reference product

351(a)BLA 103375

Bioclate (Armour), Recombinate Antihemophilic Factor (Recombinant)

Takeda Pharmaceuticals U.S.A., Inc.

Approved
Mar 10, 2010
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    16 yr 6 mo ago

Frequently asked questions

Are there biosimilars approved for Antihemophilic Factor (Recombinant) (Bioclate (Armour), Recombinate)?

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

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

Open the Purple Book tool