Purple Book reference family · 351(a) biologic
atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb)
atoltivimab, maftivimab, and odesivimab-ebgn is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc..
351(a) biologicBLA 761169 Regeneron Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2020
Reference product
Originator biologic
351(a)BLA 761169
Inmazeb atoltivimab, maftivimab, and odesivimab-ebgn
Regeneron Pharmaceuticals, 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 atoltivimab, maftivimab, and odesivimab-ebgn product.
6 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 1 mo
atoltivimab, maftivimab, and odesivimab-ebgn: 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 atoltivimab, maftivimab, and odesivimab-ebgn.
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