enfortumab vedotin-ejfv (Padcev)
enfortumab vedotin-ejfv is an FDA-licensed reference biologic from Astellas Pharma US, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Padcev enfortumab vedotin-ejfv
Astellas Pharma US, Inc.
- Approved
- Dec 18, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for enfortumab vedotin-ejfv, in chronological order.
Reference approval
Approval date of the reference enfortumab vedotin-ejfv product.
6 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for enfortumab vedotin-ejfv (Padcev)?
No 351(k) biosimilars or interchangeable biosimilars referencing enfortumab vedotin-ejfv are listed in the FDA Purple Book yet.
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