Purple Book reference family · 351(a) biologic
tositumomab and iodine I-131 tositumomab (Bexxar)
tositumomab and iodine I-131 tositumomab is an FDA-licensed reference biologic from GlaxoSmithKline LLC.
351(a) biologicBLA 125011 GlaxoSmithKline LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2003
Reference product
Originator biologic
351(a)BLA 125011
Bexxar tositumomab and iodine I-131 tositumomab
GlaxoSmithKline LLC
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 tositumomab and iodine I-131 tositumomab product.
23 yr 5 mo ago
tositumomab and iodine I-131 tositumomab: 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 tositumomab and iodine I-131 tositumomab.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
