[Medicine News] Huahai's heavy-duty generic drugs are the first to enter the US market of more than 5 billion yuan. The first one in China will come out, and the battle for a big cake will be fierce!

On May 23, Zhejiang Huahai Pharmaceutical Co., Ltd received a notice from the U.S Food and Drug Administration (hereinafter referred to as the "FDA") that the new drug application for rivaroxaban tablets (anda) has been temporarily approved (temporary approval: refers to a form of approval that FDA has completed all the review requirements for generic drugs, but due to the patent or monopoly rights are not expired) Mark that the product has passed all the evaluation requirements of generic drugs Finally, the product will not be eligible for sale in the U.S market until the patent expires and FDA finally approves it According to the announcement, Huahai has invested about 14.705 million yuan in the research and development of the project Basic information of the drug 1 Drug name: rivaroxaban 2 Anda No.: 208549 3 Dosage form: tablet 4 Specification: 10mg, 15mg, 20mg 5 Application items: anda 6 Applicant: Prinston pharmaceutical, The market trend of Inc is strong, and the big cake division is coming Rivaroxaban tablets are jointly developed by Bayer and Janssen, and approved by the European Drug Administration (EMA) on September 30, 2008, and FDA on July 1, 2011 Rivaroxaban tablet is mainly used to treat adult patients undergoing selective hip or knee replacement to prevent venous thrombosis (VTE) The patent of the drug compound expires in 2020 At present, only the original product is on the market Rivaroxaban is a selective clotting factor Xa inhibitor Since the drug was put on the market, the market trend has been strong In 2017, rivaroxaban is second only to apixaban in the global cardiovascular system drugs, ranking second in sales In 2018, Bayer sold 3631 million euros and Johnson & Johnson sold 2477 million US dollars, equivalent to about 44.71 billion yuan in total According to the Huahai announcement, the US market alone has sales of about US $5.158 billion The temporary approval of Huahai has taken a big step When the patent expires, Huahai will seize the cake in the U.S market Domestic imitation is hot, 15 enterprises report production, and the first imitation will come out in the domestic market Bayer's rivaroxaban entered China in June 2009 (trade name: byritol) for the prevention of venous thrombosis after selective total hip or total knee arthroplasty in adults In May 2015, two new indications of rivaroxaban tablets were approved by CFDA, respectively, for the treatment and prevention of deep vein thrombosis and pulmonary embolism, and stroke prevention in patients with atrial fibrillation Domestic enterprises are optimistic about the potential of rivaroxaban According to Huahai announcement, the sales volume of rivaroxaban's domestic hospital market in 2018 is about 1.527 billion yuan And the drug has entered class B of 2017 national medical insurance catalogue, which is limited to warfarin in the treatment of patients with non valvular atrial fibrillation and patients with lower extremity joint replacement surgery with poor control or high risk of bleeding At present, there is a fierce competition among enterprises in imitation According to the registration and acceptance database of pharmaceutical intelligence, there are 63 acceptance numbers for generic drugs of rivaroxaban, 40 of 42 acceptance numbers for generic drugs of the old 6 categories have been approved for clinical application; 21 acceptance numbers for generic drugs of the new 4 categories have been approved, involving 15 enterprises, including such powerful enterprises as Huahai, Zhengda Tianqing, Shiyao Ouyi, Yangzi River, etc Inside However, according to the latest review and approval information of drug intelligence data, on May 13, the "rivaroxaban tablets" of Suzhou No.3 pharmaceutical factory showed "under approval" Take the lead in entering the approval stage, or become the first to obtain approval According to the market prospect, other enterprises are bound to speed up and strive for approval in 2020 to gain access to the big market If Huahai pharmaceutical is approved by FDA and internationally recognized, it may have certain advantages in opening up domestic market Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.