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FDA Purple Book · Reference family

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.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2000

Reference approved

Reference product

351(a)BLA 101447

Autoplex, Feiba Nf, Feiba Vh Anti-Inhibitor Coagulant Complex

Takeda Pharmaceuticals U.S.A., Inc.

Approved
Jul 31, 2000
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Anti-Inhibitor Coagulant Complex, in chronological order.

  1. Reference approval

    Approval date of the reference Anti-Inhibitor Coagulant Complex product.

    26 yr 3 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    5 yr 6 mo ago

Frequently asked questions

Are there biosimilars approved for Anti-Inhibitor Coagulant Complex (Autoplex, Feiba Nf, Feiba Vh)?

No 351(k) biosimilars or interchangeable biosimilars referencing Anti-Inhibitor Coagulant Complex are listed in the FDA Purple Book yet.

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