brentuximab vedotin (Adcetris)
brentuximab vedotin is an FDA-licensed reference biologic from Seagen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2011
Reference approved
Reference product
Adcetris brentuximab vedotin
Seagen Inc.
- Approved
- Aug 19, 2011
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for brentuximab vedotin, in chronological order.
Reference approval
Approval date of the reference brentuximab vedotin product.
15 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 6 mo
Frequently asked questions
Are there biosimilars approved for brentuximab vedotin (Adcetris)?
No 351(k) biosimilars or interchangeable biosimilars referencing brentuximab vedotin are listed in the FDA Purple Book yet.
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