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FDA Purple Book · Reference family

Immune Globulin Subcutaneous (Human) (Vivaglobin)

Immune Globulin Subcutaneous (Human) is an FDA-licensed reference biologic from CSL Behring GmbH. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2006

Reference approved

Reference product

351(a)BLA 125115

Vivaglobin Immune Globulin Subcutaneous (Human)

CSL Behring GmbH

Approved
Jan 09, 2006
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    20 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for Immune Globulin Subcutaneous (Human) (Vivaglobin)?

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

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