Yes the Intrinsic LifeSciences hepcidin assay and tracer are patented (Patent # 7,723,063 and 7,745,162).
Currently the hepcidin assay is not FDA approved. However, it has been validated in several peer-reviewed studies and is marketed as a Research Use Only assay. The validation results are reported in articles by Ganz et al. (Blood, 2008 112: 4292-7), Young et al. (American Journal of Clinical Nutrition, 2009 89:533-8) and Melis et al. (Haematologica, 2008, 93:1473-9). We have performed hepcidin analysis for academic, clinical, government and pharmaceutical customers, worldwide.