Drug

Gadoquatrane

As of the edition of 20 October 2026, Gadoquatrane is a small molecule: marketed, first approved in 2026 (US); US protection ends in 2036.

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
Ambelvist
First approved
12 June 2026 (US)
Approvals on record
10 in 3 regions
Holder of the most recent approval
Bayer; 2 holders in all
Registered trials
7, 0 stopped early

US protection

US protection ends in 2036.

The last listed US drug-substance patent ends in 2036. 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

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

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 13300
Phase 21100
Phase 33300
All trials7

Who has held its approvals

CompanyRoleYears
BayerOriginator, Applicant and Lead sponsor of trials2019 to now