Purple Book reference family · 351(a) biologic
vedolizumab (Entyvio)
vedolizumab is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc..
351(a) biologicBLA 761133 Takeda Pharmaceuticals U.S.A., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 761133
Entyvio vedolizumab
Takeda Pharmaceuticals U.S.A., 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 vedolizumab product.
2 yr 10 mo ago
vedolizumab: 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 vedolizumab.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
