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
Bioclate (Armour), Recombinate Antihemophilic Factor (Recombinant)
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Mar 10, 2010
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Molecular structure
Experimental 3D structure for Antihemophilic Factor (Recombinant) from the RCSB Protein Data Bank (PDB 3CDZ).
Interactive biological assembly from PDB entry 3CDZ. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor (Recombinant), in chronological order.
Reference approval
Approval date of the reference Antihemophilic Factor (Recombinant) product.
16 yr 7 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.