Purple Book reference family · 351(a) biologic
tbo-filgrastim (Granix)
tbo-filgrastim is an FDA-licensed reference biologic from UAB Teva Baltics.
351(a) biologicBLA 125294 UAB Teva Baltics
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018
Reference product
Originator biologic
351(a)BLA 125294
Granix tbo-filgrastim
UAB Teva Baltics
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference tbo-filgrastim product.
8 yr 1 mo ago
tbo-filgrastim: 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 tbo-filgrastim.
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