Purple Book reference family · 351(a) biologic
Fibrin Sealant (Tisseel) (Tisseel)
Fibrin Sealant (Tisseel) is an FDA-licensed reference biologic from Baxter Healthcare Corporation.
351(a) biologicBLA 103980 Baxter Healthcare Corporation
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1998
Reference product
Originator biologic
351(a)BLA 103980
Tisseel Fibrin Sealant (Tisseel)
Baxter Healthcare 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 Fibrin Sealant (Tisseel) product.
28 yr 8 mo ago
Fibrin Sealant (Tisseel): 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 (Tisseel).
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