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Purple Book reference family · 351(a) biologic

Fibrin Sealant (Human) (Artiss)

Fibrin Sealant (Human) is an FDA-licensed reference biologic from Baxter Healthcare Corporation.

351(a) biologicBLA 125266 Baxter Healthcare Corporation
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2008

Reference product

Originator biologic
351(a)BLA 125266

Artiss Fibrin Sealant (Human)

Baxter Healthcare Corporation

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

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

    18 yr 7 mo ago

Fibrin Sealant (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 Fibrin Sealant (Human).

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