Purple Book reference family · 351(a) biologic
fibrinogen, human–chmt (FESILTY)
fibrinogen, human–chmt is an FDA-licensed reference biologic from Grifols Therapeutics LLC.
351(a) biologicBLA 125833 Grifols Therapeutics LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 125833
FESILTY fibrinogen, human–chmt
Grifols Therapeutics LLC
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 fibrinogen, human–chmt product.
8 mo ago
fibrinogen, human–chmt: 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 fibrinogen, human–chmt.
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