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FDA Purple Book · Reference family

Antihemophilic Factor (Recombinant), Plasma/Albumin Free (Xyntha, Xyntha Solofuse)

Antihemophilic Factor (Recombinant), Plasma/Albumin Free is an FDA-licensed reference biologic from Wyeth Pharmaceuticals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2008

Reference approved

Reference product

351(a)BLA 125264

Xyntha, Xyntha Solofuse Antihemophilic Factor (Recombinant), Plasma/Albumin Free

Wyeth Pharmaceuticals LLC

Approved
Feb 21, 2008
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference Antihemophilic Factor (Recombinant), Plasma/Albumin Free product.

    18 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for Antihemophilic Factor (Recombinant), Plasma/Albumin Free (Xyntha, Xyntha Solofuse)?

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

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