Purple Book reference family · 351(a) biologic
brentuximab vedotin (Adcetris)
brentuximab vedotin is an FDA-licensed reference biologic from Seagen Inc..
351(a) biologicBLA 125388 Seagen Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2011
Reference product
Originator biologic
351(a)BLA 125388
Adcetris brentuximab vedotin
Seagen Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference brentuximab vedotin product.
15 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 2 mo
brentuximab vedotin: 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 brentuximab vedotin.
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