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FDA Purple Book · Reference family

Immune Globulin (Human) (Baygam, Gamastan S/D)

Immune Globulin (Human) is an FDA-licensed reference biologic from Grifols Therapeutics LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1944

Reference approved

Reference product

351(a)BLA 101134

Baygam, Gamastan S/D Immune Globulin (Human)

Grifols Therapeutics LLC

Approved
Jan 11, 1944
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    83 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for Immune Globulin (Human) (Baygam, Gamastan S/D)?

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

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