FDA Purple Book · Reference family
tbo-filgrastim (Granix)
tbo-filgrastim is an FDA-licensed reference biologic from UAB Teva Baltics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
351(a)BLA 125294
Granix tbo-filgrastim
UAB Teva Baltics
- Approved
- Jul 31, 2018
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tbo-filgrastim, in chronological order.
Reference approval
Approval date of the reference tbo-filgrastim product.
7 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for tbo-filgrastim (Granix)?
No 351(k) biosimilars or interchangeable biosimilars referencing tbo-filgrastim are listed in the FDA Purple Book yet.
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