Drug

Nifurtimox

As of the edition of 20 October 2026, Nifurtimox is a small molecule: marketed, first approved in 2020 (US); US protection ends in 2027.

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

The drug

Status
Marketed; latest approval 2026
Kind
Small molecule
Brand name
Lampit
First approved
6 August 2020 (US)
Approvals on record
4 in 3 regions
Holder of the most recent approval
Bayer; 2 holders in all
Registered trials
13, 0 stopped early
Disease areas
Infections; Cancer

US protection

US protection ends in 2027.

The last listed US exclusivity ends in 2027. The application that gives this date is held by Bayer.

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 stated2110
Phase 16600
Phase 22200
Phase 33200
All trials13

Who has held its approvals

CompanyRoleYears
BayerOriginator, Applicant and Lead sponsor of trials2013 to now