2025.01.Dapagliflozin,Markets and News,API,Dapagliflozin Propanediol monohydrate,960404-48-2

In the field of diabetes treatment drugs, dapagliflozin has become one of the most closely watched drugs due to its unique mechanism of action and good therapeutic effect. A thorough understanding of dapagliflozin in all aspects is of great significance to medical industry practitioners, investors, and those concerned with diabetes treatment. 

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I. Basic Introduction 

Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor developed by AstraZeneca, which exerts hypoglycemic effects by promoting urinary glucose excretion. Clinically, it can be used as a monotherapy or in combination with other antidiabetic drugs to treat type 2 diabetes, with significant efficacy and high safety. Currently, dapagliflozin has been approved for multiple indications in China, including type 2 diabetes (T2D), heart failure with reduced ejection fraction (HFrEF), and chronic kidney disease (CKD). 

It is worth mentioning that 5-bromo-2-chlorobenzoic acid is an important intermediate in the production of dapagliflozin. According to QYResearch's research, the market size of 5-bromo-2-chlorobenzoic acid in China reached 91.8709 million yuan in 2022 and is expected to reach 134 million yuan in 2029, with a compound annual growth rate (CAGR) of 5.23%. Among them, the market share of 5-bromo-2-chlorobenzoic acid used for dapagliflozin production reached 85.54% in 2022. 

Empagliflozin, a member of the SGLT2 inhibitor class like dapagliflozin, was developed by Boehringer Ingelheim and Eli Lilly. It is a new-generation SGLT2 inhibitor. Besides lowering blood sugar and glycated hemoglobin, it can significantly reduce the risk of cardiovascular complications and cardiovascular death in adult patients with diabetes and heart disease. It has been approved in China for the treatment of adult type 2 diabetes, heart failure with reduced ejection fraction in adults, heart failure with preserved ejection fraction in adults, type 2 diabetes in combination with insulin, and adult chronic kidney disease. Currently, domestic enterprises such as Jiangsu Hansoh and Sichuan Kelun have entered the empagliflozin market. 

II. Introduction to the Original Research Manufacturer 

Dapagliflozin was jointly developed by Bristol-Myers Squibb and AstraZeneca. Bristol-Myers Squibb has a profound research and development background in cardiovascular and oncology fields; AstraZeneca has achieved remarkable results in respiratory, cardiovascular and metabolic treatment areas. The collaboration between the two parties has promoted the successful development of dapagliflozin. 

III. Time of Market Approval 

In November 2012, dapagliflozin was approved for marketing by the European Medicines Agency (EMA); in January 2014, it was approved by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes. 

IV. Patent Situation of Core Compounds 

It is worth noting that the originator company of dapagliflozin tablets, a multinational pharmaceutical company headquartered in the UK, has extended its patent protection period to March 2028 through a crystal form patent. This means that if domestic pharmaceutical research and development enterprises develop an innovative crystal form independently, they can break through the patent barrier of the originator drug and enable the generic dapagliflozin tablets to be legally launched earlier. Guided by the mission of "enabling patients to access good drugs earlier and at an affordable price", Fangshenghe Pharmaceutical has creatively achieved a breakthrough in crystal form patents and officially submitted a drug registration application for dapagliflozin tablets to the Center for Drug Evaluation of the National Medical Products Administration on April 22, 2022, which was accepted. According to the "Interim Measures for the Early Resolution of Pharmaceutical Patent Disputes" of China, Fangshenghe Pharmaceutical simultaneously submitted a patent declaration stating that its product did not fall within the scope of protection of the crystal form patent registered by the originator company on the China National Pharmaceutical Patent Information Registration Platform. However, the originator company promptly requested an administrative ruling from the National Intellectual Property Administration, claiming that Fangshenghe Pharmaceutical's dapagliflozin tablets fell within the scope of its patent protection. After Fangshenghe Pharmaceutical's evidence presentation and the strict review by the National Intellectual Property Administration, it was confirmed that Fangshenghe Pharmaceutical's dapagliflozin tablets were not restricted by the originator company's patent rights. In November of the same year, the originator company submitted a written application to the National Intellectual Property Administration to withdraw the administrative ruling request. One week later, the National Intellectual Property Administration issued the corresponding administrative ruling conclusion notice for the drug patent dispute. On December 18, 2023, Fangshenghe Pharmaceutical's Hetingjing successfully obtained the drug registration certificate with the national drug approval number from the National Medical Products Administration. On March 12, 2024, Hetingjing was officially launched nationwide, four years earlier than the expiration date of the originator company's patent protection period. This achievement has enabled Fangshenghe Pharmaceutical to advance more steadily in the generic drug race. As the commercialization year of Hetingjing in 2024, its huge market potential has been fully revealed, with cumulative entry into over 3,000 medical terminals across the country, saving hundreds of millions of yuan in expenditures for national medical insurance and diabetic patients throughout the year. 

V. Time of Listing in China 

In March 2017, dapagliflozin was officially approved for marketing in China, bringing a new treatment option to patients with type 2 diabetes in the country. 

VI. Global Sales Revenue 

Dapagliflozin has performed exceptionally well in the global market. AstraZeneca's 2023 financial report shows that Dapagliflozin's sales increased by 39% to 5.963 billion US dollars, making it the company's top-selling product and demonstrating its strong competitiveness in the global market. 

VII. Sales in China 

In China, dapagliflozin is the most widely used SGLT2 inhibitor. Data from the DrugCompass National Hospital Database shows that the sales of dapagliflozin tablets reached 3.863 billion yuan in 2023. Combining hospital and retail sales data, the total sales of dapagliflozin in 2023 were as high as 5.8 billion yuan, ranking first. According to the quarterly report of its manufacturing company for the first quarter of 2024, the sales of dapagliflozin in China in 2024 may exceed 7 billion yuan. "The overall market size of metformin and other oral hypoglycemic drugs' compound preparations is increasing year by year." Data from the Zhongkang Kaishi system shows that the retail market sales in 2023 were 992 million yuan, and the sales in the first half of 2024 have already reached 544 million yuan. In the 2023 national retail terminal oral hypoglycemic drugs sales top 10 ranking, metformin and dapagliflozin ranked first and second respectively, with sales reaching 3.042 billion yuan and 2.363 billion yuan respectively, among which the sales growth rate of dapagliflozin was 21.5%. 

VIII. Market Competition 

In the market for diabetes treatment drugs, dapagliflozin faces fierce competition. Unlike empagliflozin, which holds the "world's number one" position with annual sales of over 10 billion US dollars, dapagliflozin leads in the usage of SGLT2 inhibitors in China. Traditional hypoglycemic drugs such as metformin, with their long-term clinical application and price advantages, hold a certain market share; other products in the same category of SGLT2 inhibitors are also vying for the market. Currently, domestic enterprises such as Shandong Luhua Pharmaceutical and Beijing Fuyuan Pharmaceutical have entered the dapagliflozin market, further intensifying the competition. 

IX. Generic Drugs 

The original research product of this drug was developed by AstraZeneca and was approved by the FDA for marketing on October 30, 2014, under the trade name Xigduo XR. In February 2019, dapagliflozin and metformin extended-release tablets were approved for a new indication, suitable for patients with type 2 diabetes and moderate renal impairment. Public data shows that in 2023, the global sales volume of dapagliflozin and metformin extended-release tablets was approximately 2 billion tablets, with sales revenue of about 1.6 billion US dollars. 

In China, in February 2022, AstraZeneca submitted an application for the marketing of dapagliflozin and metformin extended-release tablets to the National Medical Products Administration. The application was approved in June 2023. In November 2023, AstraZeneca announced the official launch of dapagliflozin and metformin extended-release tablets in China under the brand name Andaxia. In December 2023, dapagliflozin and metformin extended-release tablets were included in the medical insurance coverage. 

According to the information on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Xuantai Pharmaceutical began submitting its marketing application for the drug in September 2022. Following Xuantai Pharmaceutical, starting from 2023, nine other enterprises including Chia Tai Tianqing, Fuyuan Pharmaceutical, Huahai Pharmaceutical, and Qilu Pharmaceutical have successively submitted marketing applications for dapagliflozin and metformin extended-release tablets. On the evening of September 18th, the reporter saw on several online drug purchase platforms that the current price of the original drug Andaxia dapagliflozin and metformin extended-release tablets (I) 10mg/1000mg*28 tablets per box ranged from 97 yuan to 125 yuan. With the successive approval and listing of domestic generic drugs, the drug will also face a new competitive landscape. Xuantai Pharmaceutical's first generic drug "Dapagliflozin and Metformin Extended-Release Tablets" (trademark name: Aoruiyi) was approved for marketing by the National Medical Products Administration of China in September 2024, becoming the first approved generic drug of this variety in China. After intense production and sales preparations, on January 6, 2025, the first commercial batch of the product was successfully loaded and dispatched from Xuantai Pharmaceutical's production base - Jiangsu Xuantai Pharmaceutical Co., Ltd., marking the official launch of the product in the Chinese market and making it the first generic drug to be marketed in China. This will be conducive to Xuantai Pharmaceutical's continuous expansion of sales in the Chinese market and will have a positive impact on the company's operating performance. 

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Editor | Xiaoxin 

Reviewed by Xiaojing and Xiaoli 

Information sources | Chatgpt AI, FDA, Wikipedia, National Healthcare Security Administration, Baidu Baike 

Doctor Li Talks About Health: Dapagliflozin, with an annual sales of 7 billion, here are 5 key points you must know to use it properly! 

People's Daily Health Client: Nine pharmaceutical companies are competing for the 3.8 billion yuan dapagliflozin tablet market, with Xuantai Medicine being the first to receive approval. 

Nanjing Daily: Relying on technological innovation to secure large orders 

Xuantai Pharmaceutical's official WeChat account: Xuantai Pharmaceutical's first generic drug "Dapagliflozin and Metformin Extended-release Tablets" has officially been launched and is available for sale in the Chinese market. 

Yicai: The latest version of the National Drug List has been finally released. 

QY Market Research Report: It is projected that the global market size of 5-bromo-2-chlorobenzoic acid will reach 13.360 million yuan by 2029. 

Image source | AI-generated illustration, not an actual product image 

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