isatuximab-irfc (Sarclisa)
isatuximab-irfc is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2020
Reference approved
Reference product
Sarclisa isatuximab-irfc
Sanofi-Aventis U.S. LLC
- Approved
- Mar 02, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for isatuximab-irfc, in chronological order.
Reference approval
Approval date of the reference isatuximab-irfc product.
6 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 5 mo
Frequently asked questions
Are there biosimilars approved for isatuximab-irfc (Sarclisa)?
No 351(k) biosimilars or interchangeable biosimilars referencing isatuximab-irfc are listed in the FDA Purple Book yet.
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