Purple Book reference family · 351(a) biologic
enfortumab vedotin-ejfv (Padcev)
enfortumab vedotin-ejfv is an FDA-licensed reference biologic from Astellas Pharma US, Inc..
351(a) biologicBLA 761137 Astellas Pharma US, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 761137
Padcev enfortumab vedotin-ejfv
Astellas Pharma US, 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 enfortumab vedotin-ejfv product.
6 yr 8 mo ago
enfortumab vedotin-ejfv: 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 enfortumab vedotin-ejfv.
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