Assyro AI
FDA Purple Book · Reference family

fibrinogen, human�chmt (FESILTY)

fibrinogen, human�chmt is an FDA-licensed reference biologic from Grifols Therapeutics LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2025

Reference approved

Reference product

351(a)BLA 125833

FESILTY fibrinogen, human�chmt

Grifols Therapeutics LLC

Approved
Dec 16, 2025
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for fibrinogen, human�chmt, in chronological order.

  1. Reference approval

    Approval date of the reference fibrinogen, human�chmt product.

    6 mo ago

Frequently asked questions

Are there biosimilars approved for fibrinogen, human�chmt (FESILTY)?

No 351(k) biosimilars or interchangeable biosimilars referencing fibrinogen, human�chmt are listed in the FDA Purple Book yet.

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

Open the Purple Book tool