Drug

Atoltivimab

As of the edition of 20 October 2026, Atoltivimab is an antibody: marketed, first approved in 2020 (US); US protection ends in 2032.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2020
Kind
Antibody
Brand name
Inmazeb
First approved
14 October 2020 (US)
Approvals on record
2 in 1 region
Holder of the most recent approval
Regeneron
Registered trials
4, 0 stopped early
Disease areas
Infections

US protection

US protection ends in 2032.

US protection ends in 2032, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Regeneron. The date is computed, not published.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 11100
Phase 21010
Phase 31010
All trials4

Who ran its trials

CompanyRoleYears
RegeneronLead sponsor of trials