rozanolixizumab-noli (Rystiggo)
rozanolixizumab-noli is an FDA-licensed reference biologic from UCB, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
Rystiggo rozanolixizumab-noli
UCB, Inc.
- Approved
- Jun 14, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for rozanolixizumab-noli, in chronological order.
Reference approval
Approval date of the reference rozanolixizumab-noli product.
2 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 2 mo
Frequently asked questions
Are there biosimilars approved for rozanolixizumab-noli (Rystiggo)?
No 351(k) biosimilars or interchangeable biosimilars referencing rozanolixizumab-noli are listed in the FDA Purple Book yet.
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