Drug

Margetuximab

As of the edition of 20 October 2026, Margetuximab is an antibody: marketed, first approved in 2020 (US); acts on ERBB2; 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
Margenza
First approved
16 December 2020 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
MacroGenics
Registered trials
11, 1 stopped early
Disease areas
Cancer; Skin and connective tissue; Digestive system; Blood and lymph; Hormones; Lungs and airways

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 MacroGenics. 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

1 listing counts towards this date. The exact date and each listing are in the product.

See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Margetuximab.

Target

GeneProteinUniProt
ERBB2Receptor tyrosine-protein kinase erbB-2P04626

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 13300
Phase 25211
Phase 32200
All trials11

Who has held its approvals

CompanyRoleYears
MacroGenicsOriginator and Lead sponsor of trials2010 to now