Huahai Pharmaceutical Co., Ltd.: new specification supplement application of doxycycline hydrochloride sustained release tablets has obtained FDA temporary approval number

On June 19, Huahai pharmaceutical announced that the company's supplementary application for the new specifications of doxycycline hydrochloride sustained-release tablets declared to the US FDA was temporarily approved by the US FDA, marking that the product has passed all the review requirements of generic drugs, but the products of this specification need to be sold in the US market after the patent expires and the final approval of the FDA It is reported that pulinstone Pharmaceutical Co., Ltd is a holding subsidiary of Huahai (USA) International Co., Ltd., a wholly-owned subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd The brief application for new drug of doxycycline hydrochloride sustained-release tablets (specification: 50mg, 150mg, 200mg) declared by the company to the US FDA has been officially approved; the supplementary application for doxycycline hydrochloride sustained-release tablets has added 120mg specification Doxycycline hydrochloride sustained-release tablet is a broad-spectrum antibiotic of tetracycline The original drug of doxycycline hydrochloride sustained-release tablets was developed by Mayne pharma company, and was approved to be listed in the United States as early as 2008 At present, in the United States, doxycycline hydrochloride sustained-release tablets 120mg dosage form is subject to patent protection, and the manufacturer of this specification product is only the original research Mayne pharma Doxycycline hydrochloride takes doxycycline as the common name in China The approved dosage forms include tablets, capsules, injections and other dosage forms The manufacturers mainly include Jiangsu Lianhuan Pharmaceutical Co., Ltd and Haikou Qili Pharmaceutical Co., Ltd and so on At present, no sustained-release tablet dosage forms have been approved for sale in China According to the query, the sales volume of doxycycline hydrochloride sustained-release tablets 120mg dosage form products in the U.S market in 2018 is about 12.6179 million US dollars (data from IMS database); the sales volume of doxycycline (doxycycline) preparation products (including all approved dosage form products) in domestic hospitals in 2018 is about 87.84 million yuan (data from Xianda database) Up to now, the company has invested 6.95 million yuan in the research and development of doxycycline hydrochloride sustained-release tablets 120mg This supplementary application for new specification (120mg) of doxycycline hydrochloride sustained-release tablets has obtained the FDA temporary approval number, which indicates that the product has passed all the review requirements of generic drugs, but the product of this specification needs to be qualified for sale in the U.S market only after the patent expires and the final approval of FDA.