Purple Book reference family · 351(a) biologic
Anti-Inhibitor Coagulant Complex (Autoplex, Feiba Nf, Feiba Vh)
Anti-Inhibitor Coagulant Complex is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc..
351(a) biologicBLA 101447 Takeda Pharmaceuticals U.S.A., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000
Reference product
Originator biologic
351(a)BLA 101447
Autoplex, Feiba Nf, Feiba Vh Anti-Inhibitor Coagulant Complex
Takeda Pharmaceuticals U.S.A., Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Anti-Inhibitor Coagulant Complex product.
26 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 10 mo ago
Anti-Inhibitor Coagulant Complex: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Anti-Inhibitor Coagulant Complex.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

