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FDA Purple Book · Reference family

Antihemophilic Factor/von Willebrand Factor Complex (Human) (Alphanate)

Antihemophilic Factor/von Willebrand Factor Complex (Human) is an FDA-licensed reference biologic from Grifols Biologicals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1978

Reference approved

Reference product

351(a)BLA 102475

Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human)

Grifols Biologicals LLC

Approved
Aug 15, 1978
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor/von Willebrand Factor Complex (Human), in chronological order.

  1. Reference approval

    Approval date of the reference Antihemophilic Factor/von Willebrand Factor Complex (Human) product.

    48 yr 6 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    12 yr 6 mo ago

Frequently asked questions

Are there biosimilars approved for Antihemophilic Factor/von Willebrand Factor Complex (Human) (Alphanate)?

No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic Factor/von Willebrand Factor Complex (Human) are listed in the FDA Purple Book yet.

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