FDA Purple Book · Reference family
tisotumab vedotin-tftv (Tivdak)
tisotumab vedotin-tftv 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
2021
Reference approved
Reference product
351(a)BLA 761208
Tivdak tisotumab vedotin-tftv
Seagen Inc.
- Approved
- Sep 20, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tisotumab vedotin-tftv, in chronological order.
Reference approval
Approval date of the reference tisotumab vedotin-tftv product.
4 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for tisotumab vedotin-tftv (Tivdak)?
No 351(k) biosimilars or interchangeable biosimilars referencing tisotumab vedotin-tftv are listed in the FDA Purple Book yet.
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