fam-trastuzumab deruxtecan-nxki (Enhertu)
fam-trastuzumab deruxtecan-nxki is an FDA-licensed reference biologic from Daiichi Sankyo, Inc. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Enhertu fam-trastuzumab deruxtecan-nxki
Daiichi Sankyo, Inc
- Approved
- Dec 20, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for fam-trastuzumab deruxtecan-nxki, in chronological order.
Reference approval
Approval date of the reference fam-trastuzumab deruxtecan-nxki product.
6 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 8 mo
Frequently asked questions
Are there biosimilars approved for fam-trastuzumab deruxtecan-nxki (Enhertu)?
No 351(k) biosimilars or interchangeable biosimilars referencing fam-trastuzumab deruxtecan-nxki are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.