Purple Book reference family · 351(a) biologic
Anti-thymocyte Globulin (Rabbit) (Thymoglobulin)
Anti-thymocyte Globulin (Rabbit) is an FDA-licensed reference biologic from Genzyme Corporation.
351(a) biologicBLA 103869 Genzyme Corporation
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1999
Reference product
Originator biologic
351(a)BLA 103869
Thymoglobulin Anti-thymocyte Globulin (Rabbit)
Genzyme Corporation
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 Anti-thymocyte Globulin (Rabbit) product.
27 yr 7 mo ago
Anti-thymocyte Globulin (Rabbit): 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 Anti-thymocyte Globulin (Rabbit).
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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.

