Deferasirox

In the long-term treatment of diseases such as transfusion-dependent thalassemia and myelodysplastic syndrome, iron overload is the core complication that leads to organ damage and shortened survival of patients. Traditional iron chelating agents have clinical pain points such as inconvenient administration and frequent adverse reactions. The advent of deferasirox has filled the gap of oral treatment in this field. As the first oral iron chelator, it can bind to free iron in vivo and ferric ions in ferritin with high selectivity to form stable water-soluble chelates that are excreted in feces, significantly reducing the iron load in vital organs such as the heart and liver. It has currently been recommended by multiple global guidelines as the first-line treatment for patients with transfusion-associated iron overload aged 2 years and above, and can also be used for iron overload management in patients with non-transfusion-dependent thalassemia aged 10 years and above.

The global deferasirox market size exceeded US$1.2 billion in 2022. Driven by factors such as the popularization of thalassemia screening in developing countries and the rising incidence of myelodysplastic syndrome, the compound annual growth rate from 2025 to 2030 is expected to remain at approximately 4.7%. In terms of the domestic market, after the product was included in the National Medical Insurance Catalog in 2017, its clinical accessibility has been greatly improved. The sales volume at public hospital terminals exceeded RMB 1.8 billion in 2023. A competitive landscape coexisting of the original drug and domestic generic drugs has been formed at present. Generic drugs from 4 domestic enterprises have been approved for marketing, and the price has dropped by more than 90% after centralized procurement, further driving the release of clinical demand.

The original developer of deferasirox is Novartis, and the original brand name is Exjade. Its core compound patent expired in the United States in 2023, and the Chinese compound patent expired in 2021. The main dosage form approved for the original drug is dispersible tablets, available in three specifications: 125mg, 250mg and 500mg, and an oral suspension dosage form is also available on the market. The original product of this variety has been included in the China Listed Medicines Catalogue as the reference listed drug, and is also listed in the FDA Reference Listed Drug Catalog. Up to now, the deferasirox active pharmaceutical ingredients (APIs) from more than 10 domestic enterprises have completed registration with the Center for Drug Evaluation (CDE) and obtained Class A status, and the API registrations of more than 20 other enterprises are under review and approval process. Deferasirox dispersible tablets from 6 enterprises have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for deferasirox API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The relevant reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable material basis support for relevant pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.