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FDA Purple Book · Reference family

Pooled Plasma (Human), Solvent/Detergent Treated (Octaplas)

Pooled Plasma (Human), Solvent/Detergent Treated is an FDA-licensed reference biologic from Octapharma Pharmazeutika Produktionsges.m.b.H.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2013

Reference approved

Reference product

351(a)BLA 125416

Octaplas Pooled Plasma (Human), Solvent/Detergent Treated

Octapharma Pharmazeutika Produktionsges.m.b.H.

Approved
Jan 17, 2013
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Pooled Plasma (Human), Solvent/Detergent Treated, in chronological order.

  1. Reference approval

    Approval date of the reference Pooled Plasma (Human), Solvent/Detergent Treated product.

    13 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for Pooled Plasma (Human), Solvent/Detergent Treated (Octaplas)?

No 351(k) biosimilars or interchangeable biosimilars referencing Pooled Plasma (Human), Solvent/Detergent Treated are listed in the FDA Purple Book yet.

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