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Fibrin Sealant (Human) (Artiss)

Fibrin Sealant (Human) is an FDA-licensed reference biologic from Baxter Healthcare Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2008

Reference approved

Reference product

351(a)BLA 125266

Artiss Fibrin Sealant (Human)

Baxter Healthcare Corporation

Approved
Mar 19, 2008
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference Fibrin Sealant (Human) product.

    18 yr 6 mo ago

Frequently asked questions

Are there biosimilars approved for Fibrin Sealant (Human) (Artiss)?

No 351(k) biosimilars or interchangeable biosimilars referencing Fibrin Sealant (Human) are listed in the FDA Purple Book yet.

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