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FDA Purple Book · Reference family

Anti-thymocyte Globulin (Rabbit) (Thymoglobulin)

Anti-thymocyte Globulin (Rabbit) is an FDA-licensed reference biologic from Genzyme Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1999

Reference approved

Reference product

351(a)BLA 103869

Thymoglobulin Anti-thymocyte Globulin (Rabbit)

Genzyme Corporation

Approved
May 19, 1999
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Anti-thymocyte Globulin (Rabbit), in chronological order.

  1. Reference approval

    Approval date of the reference Anti-thymocyte Globulin (Rabbit) product.

    27 yr 5 mo ago

Frequently asked questions

Are there biosimilars approved for Anti-thymocyte Globulin (Rabbit) (Thymoglobulin)?

No 351(k) biosimilars or interchangeable biosimilars referencing Anti-thymocyte Globulin (Rabbit) are listed in the FDA Purple Book yet.

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