Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) 413 announced that the company received a notice from the US Food and Drug Administration (hereinafter referred to as “FDA”) that the US generic drug application of apixaban tablets declared by the company to the US FDA has been provisionally approved (referring to a form of approval given by the FDA because the FDA has completed all the review requirements of generic drugs but the patent right or monopoly right has not expired). This indicates that the product has passed all the review requirements of generic drugs, but the product can be sold in the U.S. market only after the patent right expires and the final approval of FDA.
It is reported that apixaban tablets are mainly used to reduce the risk of stroke and systemic embolism. Apixaban tablets was developed by BMS and was listed in the United States in January 2013. Because the drug is still in the patent protection period, at present, only the original research products are sold in the U.S. market. According to IMS database, the sales volume of the drug in the US market in 2021 was about US $15.823 billion.
