Purple Book reference family · 351(a) biologic
satralizumab-mwge (Enspryng)
satralizumab-mwge is an FDA-licensed reference biologic from Genentech, Inc..
351(a) biologicBLA 761149 Genentech, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2020
Reference product
Originator biologic
351(a)BLA 761149
Enspryng satralizumab-mwge
Genentech, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference satralizumab-mwge product.
6 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 11 mo
satralizumab-mwge: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for satralizumab-mwge.
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