Purple Book reference family · 351(a) biologic
fam-trastuzumab deruxtecan-nxki (Enhertu)
fam-trastuzumab deruxtecan-nxki is an FDA-licensed reference biologic from Daiichi Sankyo, Inc.
351(a) biologicBLA 761139 Daiichi Sankyo, Inc
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 761139
Enhertu fam-trastuzumab deruxtecan-nxki
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 fam-trastuzumab deruxtecan-nxki product.
6 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 4 mo
fam-trastuzumab deruxtecan-nxki: 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 fam-trastuzumab deruxtecan-nxki.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
