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FDA Purple Book · Reference family

Tetanus Immune Globulin (Human) (Baytet, Hypertet)

Tetanus 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

1957

Reference approved

Reference product

351(a)BLA 101142

Baytet, Hypertet Tetanus Immune Globulin (Human)

Grifols Therapeutics LLC

Approved
Oct 17, 1957
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    69 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for Tetanus Immune Globulin (Human) (Baytet, Hypertet)?

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

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