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Purple Book reference family · 351(a) biologic

ublituximab-xiiy (Briumvi)

ublituximab-xiiy is an FDA-licensed reference biologic from TG Therapeutics, Inc..

351(a) biologicBLA 761238 TG Therapeutics, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2022

Reference product

Originator biologic
351(a)BLA 761238

Briumvi ublituximab-xiiy

TG Therapeutics, Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference ublituximab-xiiy product.

    3 yr 8 mo ago

ublituximab-xiiy: 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 ublituximab-xiiy.

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Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.