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FDA Purple Book · Reference family

Thrombin, Topical (Human) (Evithrom)

Thrombin, Topical (Human) is an FDA-licensed reference biologic from Omrix Biopharmaceuticals Ltd. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2009

Reference approved

Reference product

351(a)BLA 125247

Evithrom Thrombin, Topical (Human)

Omrix Biopharmaceuticals Ltd

Approved
Sep 17, 2009
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference Thrombin, Topical (Human) product.

    16 yr 11 mo ago

Frequently asked questions

Are there biosimilars approved for Thrombin, Topical (Human) (Evithrom)?

No 351(k) biosimilars or interchangeable biosimilars referencing Thrombin, Topical (Human) are listed in the FDA Purple Book yet.

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