Purple Book reference family · 351(a) biologic
datopotamab deruxtecan-dlnk (Datroway)
datopotamab deruxtecan-dlnk is an FDA-licensed reference biologic from Daiichi Sankyo, Inc.
351(a) biologicBLA 761394 Daiichi Sankyo, Inc
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 761394
Datroway datopotamab deruxtecan-dlnk
Daiichi Sankyo, 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 datopotamab deruxtecan-dlnk product.
1 yr 7 mo ago
datopotamab deruxtecan-dlnk: 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 datopotamab deruxtecan-dlnk.
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