Purple Book reference family · 351(a) biologic
Tetanus Immune Globulin (Human) (Baytet, Hypertet)
Tetanus Immune Globulin (Human) is an FDA-licensed reference biologic from Grifols Therapeutics LLC.
351(a) biologicBLA 101142 Grifols Therapeutics LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1957
Reference product
Originator biologic
351(a)BLA 101142
Baytet, Hypertet Tetanus Immune Globulin (Human)
Grifols Therapeutics LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Tetanus Immune Globulin (Human) product.
69 yr 9 mo ago
Tetanus Immune Globulin (Human): frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Tetanus Immune Globulin (Human).
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

