Purple Book reference family · 351(a) biologic
ado-trastuzumab emtansine (Kadcyla)
ado-trastuzumab emtansine is an FDA-licensed reference biologic from Genentech, Inc..
351(a) biologicBLA 125427 Genentech, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2013
Reference product
Originator biologic
351(a)BLA 125427
Kadcyla ado-trastuzumab emtansine
Genentech, 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 ado-trastuzumab emtansine product.
13 yr 7 mo ago
ado-trastuzumab emtansine: 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 ado-trastuzumab emtansine.
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