satralizumab-mwge (Enspryng)
satralizumab-mwge 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
2020
Reference approved
Reference product
Enspryng satralizumab-mwge
Genentech, Inc.
- Approved
- Aug 14, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for satralizumab-mwge, in chronological order.
Reference approval
Approval date of the reference satralizumab-mwge product.
5 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 3 mo
Frequently asked questions
Are there biosimilars approved for satralizumab-mwge (Enspryng)?
No 351(k) biosimilars or interchangeable biosimilars referencing satralizumab-mwge are listed in the FDA Purple Book yet.
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