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FDA Purple Book · Reference family

Immune Globulin Subcutaneous (Human)-hipp (Cutaquig)

Immune Globulin Subcutaneous (Human)-hipp 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

2018

Reference approved

Reference product

351(a)BLA 125668

Cutaquig Immune Globulin Subcutaneous (Human)-hipp

Octapharma Pharmazeutika Produktionsges.m.b.H.

Approved
Dec 12, 2018
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Immune Globulin Subcutaneous (Human)-hipp, in chronological order.

  1. Reference approval

    Approval date of the reference Immune Globulin Subcutaneous (Human)-hipp product.

    7 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for Immune Globulin Subcutaneous (Human)-hipp (Cutaquig)?

No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Subcutaneous (Human)-hipp are listed in the FDA Purple Book yet.

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