siltuximab (Sylvant)
siltuximab is an FDA-licensed reference biologic from Recordati Rare Diseases, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2014
Reference approved
Reference product
Sylvant siltuximab
Recordati Rare Diseases, Inc.
- Approved
- Apr 23, 2014
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for siltuximab, in chronological order.
Reference approval
Approval date of the reference siltuximab product.
12 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for siltuximab (Sylvant)?
No 351(k) biosimilars or interchangeable biosimilars referencing siltuximab are listed in the FDA Purple Book yet.
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