Prescription medicine
Atoltivimab and maftivimab and odesivimab Brand names: Inmazeb
Atoltivimab and maftivimab and odesivimab (Inmazeb) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the atoltivimab and maftivimab and odesivimab FDA label on DailyMed (effective December 15, 2025, Regeneron Pharmaceuticals, Inc.); the BLA 761169 record on Drugs@FDA; every atoltivimab and maftivimab and odesivimab label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14) ].
Forms and strengths
- 241.7 mg/14.5ml / 241.7 mg/14.5ml / 241.7 mg/14.5ml
- 483.3 mg/14.5ml / 483.3 mg/14.5ml / 483.3 mg/14.5ml
Injection (solution).
On the market
- Earliest approval on file
- October 14, 2020 Inmazeb, Regeneron Pharmaceuticals; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is atoltivimab and maftivimab and odesivimab used for?
From the label: indications and usageINMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14) ]. INMAZEB is a combination of Orthoebolavirus zairense glycoprotein-directed human monoclonal antibodies (atoltivimab, maftivimab, and odesivimab), indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection. […]
Source: FDA drug label (Inmazeb), Regeneron Pharmaceuticals, Inc., effective December 15, 2025 (SPL set 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa), via openFDA; the full label on DailyMed
Is there a generic for atoltivimab and maftivimab and odesivimab (Inmazeb)?
No generic atoltivimab and maftivimab and odesivimab is approved (Drugs@FDA, October 8, 2026).
- 2020 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What next?
- Check an interaction
- what two or more labels say about each other