FDA Purple Book · Reference family
ublituximab-xiiy (Briumvi)
ublituximab-xiiy is an FDA-licensed reference biologic from TG Therapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2022
Reference approved
Reference product
351(a)BLA 761238
Briumvi ublituximab-xiiy
TG Therapeutics, Inc.
- Approved
- Dec 28, 2022
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ublituximab-xiiy, in chronological order.
Reference approval
Approval date of the reference ublituximab-xiiy product.
3 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for ublituximab-xiiy (Briumvi)?
No 351(k) biosimilars or interchangeable biosimilars referencing ublituximab-xiiy are listed in the FDA Purple Book yet.
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