Deferiprone

Thalassemia is a type of hereditary hemolytic anemia with a high incidence in southern China. Iron overload caused by long-term blood transfusion therapy is the core cause of organ injury and even death in patients. Deferiprone, an oral bidentate pyridine iron chelator, can bind to free ferric iron in the body to form a stable water-soluble complex, which is excreted through urine to reduce the body's iron load. Compared with traditional injectable iron-chelating drugs, its advantage of oral administration greatly improves patients' treatment compliance. It is a second-line iron chelation therapy drug recommended by current guidelines, and is mainly used for the treatment of iron overload in patients with β-thalassemia aged over 6 years who are tolerant or unwilling to receive existing chelator therapy.

The global deferiprone market size has maintained steady growth in recent years. In 2023, the overall market size was approximately USD 320 million, with the Chinese market accounting for about 17%, and the compound annual growth rate reaching 8.9%. The growth momentum mainly comes from the increase in the popularity of thalassemia diagnosis and treatment and the enhancement of awareness of long-term standardized treatment. In terms of the competitive landscape, the original research product still accounts for nearly 60% of the global market share. Since the implementation of centralized procurement in 2021, the price of domestic generic drugs has dropped significantly, and the accessibility of drugs for patients has been significantly improved. At present, domestic generic drugs have occupied nearly 70% of the domestic hospital market, and the supply of active pharmaceutical ingredients is dominated by domestic enterprises, gradually realizing import substitution.

The original research enterprise of deferiprone is Apotex Inc., and the original research trade name is Ferriprox. The US compound patent expired in 2022, and the core compound patent in China expired in 2023. The approved dosage forms of the original research include tablets and oral solution, among which the specification of the tablet is 500mg, and the specification of the oral solution is 100mg/ml. The original research tablet has been included in the NMPA Reference Listed Drug Catalogue of Chemical Drugs, and is also included in the FDA Reference Listed Drug Catalogue. At present, more than 8 domestic enterprises have obtained CDE registration numbers for deferiprone active pharmaceutical ingredients, all of which are in status A. In addition, 6 enterprises have obtained marketing approval for deferiprone tablets, among which 4 have passed the generic drug consistency evaluation. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of deferiprone impurity reference standards. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products support spot supply. Spot orders placed before 16:00 can be shipped on the same day, which can provide stable reference material support for active pharmaceutical ingredient research and development, quality research and consistency evaluation work.