emicizumab-kxwh (Hemlibra)
emicizumab-kxwh is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2017
Reference approved
Reference product
Hemlibra emicizumab-kxwh
Genentech, Inc.
- Approved
- Nov 16, 2017
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for emicizumab-kxwh, in chronological order.
Reference approval
Approval date of the reference emicizumab-kxwh product.
8 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 mo ago
Frequently asked questions
Are there biosimilars approved for emicizumab-kxwh (Hemlibra)?
No 351(k) biosimilars or interchangeable biosimilars referencing emicizumab-kxwh are listed in the FDA Purple Book yet.
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