Ipragliflozin is an SGLT2 inhibitor developed for the treatment of type 2 diabetes mellitus. Developed by Astellas Pharma, it works by blocking the sodium-glucose co-transporter 2 in the kidneys, thus preventing glucose reabsorption and reducing blood sugar levels. Approved for use in Japan in 2014, Ipragliflozin has expanded into various markets, including China, where it is marketed as a therapeutic option for type 2 diabetes. This paper provides a comprehensive review of Ipragliflozin, including its development, patent status, global and Chinese market dynamics, competition, generic drug presence, and recent developments. The paper also outlines the drug's potential in the global diabetes market, particularly in the face of increasing generic competition.
Ipragliflozin, SGLT2 inhibitors, Type 2 diabetes, Astellas Pharma, patent status, global sales, China, market competition, generic drugs, API, drug approval, recent news.
Ipragliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor used for the treatment of type 2 diabetes mellitus. The drug works by inhibiting the SGLT2 protein in the proximal tubules of the kidney, preventing glucose reabsorption into the bloodstream and promoting glucose excretion through urine. This reduces blood glucose levels and is beneficial for managing type 2 diabetes. Ipragliflozin is part of a class of drugs that have revolutionized the treatment of diabetes by providing an alternative to traditional insulin therapy and oral hypoglycemic agents. Since its development and approval, Ipragliflozin has shown significant promise in improving glycemic control with fewer side effects, including a lower risk of hypoglycemia.
Ipragliflozin was developed by Astellas Pharma, a Japanese multinational pharmaceutical company known for its research and development in the areas of oncology, urology, immunology, and metabolism. Astellas Pharma is a key player in the global pharmaceutical industry and has made significant contributions to the development of novel therapies for a variety of conditions, including diabetes. The company’s research into SGLT2 inhibitors led to the creation of Ipragliflozin, which was first launched in Japan in 2014. Astellas continues to explore its potential uses in different markets and is focused on expanding its presence in the growing global diabetes treatment market.
Ipragliflozin was first approved in Japan in 2014 for the treatment of type 2 diabetes. The approval marked a significant milestone for Astellas Pharma, as it was the first SGLT2 inhibitor developed and marketed by the company. Following its success in Japan, the drug was introduced into other markets, including South Korea, Taiwan, and China. In China, Ipragliflozin received approval from the National Medical Products Administration (NMPA) in 2019 and was marketed under the brand name Suglat. The approval timeline in these regions reflects Astellas’ ongoing efforts to expand the accessibility of Ipragliflozin in key international markets.
The core compound of Ipragliflozin, like other SGLT2 inhibitors, is protected by patents. Astellas holds several patents related to the chemical composition and formulation of Ipragliflozin, ensuring that the drug remains exclusive in the market for a period of time. These patents are expected to expire in the late 2020s, after which generic competition could arise. However, the company continues to protect its intellectual property through various patent filings related to the use of the drug in combination therapies and for other medical conditions, which could extend the period of market exclusivity.
In China, Ipragliflozin was approved in 2019, marking the entry of another SGLT2 inhibitor into one of the world’s largest pharmaceutical markets. The drug is marketed as a treatment option for type 2 diabetes, offering patients an alternative to other treatments available in the region. As the Chinese diabetes market continues to expand due to an increasing diabetic population, the introduction of Ipragliflozin comes at a time when there is heightened demand for effective and accessible therapies. The drug’s competitive pricing and efficacy in lowering blood glucose levels are expected to make it a valuable addition to the market.
Globally, Ipragliflozin's sales have been moderate, especially compared to other blockbuster SGLT2 inhibitors such as dapagliflozin (Farxiga) and empagliflozin (Jardiance). Its performance in Japan has been relatively strong, and in other countries where it is available, Ipragliflozin has contributed to Astellas' revenue in the diabetes segment. However, the drug faces significant competition from well-established SGLT2 inhibitors. The introduction of generics and biosimilars in these markets could also impact future sales.
In China, Ipragliflozin has shown positive sales trends, benefiting from the rapid adoption of SGLT2 inhibitors in the treatment of type 2 diabetes. The drug’s accessibility, in combination with growing demand for diabetes treatments, has positioned it as a key player in the market. However, its market share in China is still challenged by other SGLT2 inhibitors such as dapagliflozin and empagliflozin, which have already captured significant portions of the market.
Ipragliflozin faces stiff competition in both global and Chinese markets from other SGLT2 inhibitors. The major players in this class include:
In China, generic versions of dapagliflozin and other established SGLT2 inhibitors are available, further intensifying the competition. Ipragliflozin’s pricing, effectiveness, and safety profile will determine its ability to capture a significant share of the diabetes treatment market.
As of now, there are no generic versions of Ipragliflozin available. However, with patents on SGLT2 inhibitors gradually expiring, generic competition is expected to increase in the coming years. Ipragliflozin’s patent protection will likely last for several more years, but after patent expiration, generic versions of the drug could enter the market, especially in high-demand regions such as China and Japan.
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In the past six months, there have been several important updates regarding Ipragliflozin:
Regulatory Developments: Ipragliflozin has continued to receive positive reviews in markets where it is approved. While there have been no major new approvals, Astellas Pharma has been working to expand the drug’s reach in emerging markets.
Clinical Trials: Recent studies have reaffirmed the efficacy and safety of Ipragliflozin in managing type 2 diabetes, with data supporting its use in patients with renal impairment and those with cardiovascular comorbidities. These findings could expand the drug’s indications in the future.
Market Expansion: Astellas Pharma has been focusing on the promotion of Ipragliflozin in China, where the diabetes market is experiencing rapid growth. Marketing strategies are being adjusted to better compete with other SGLT2 inhibitors available in the region.
Ipragliflozin represents a key development in the SGLT2 inhibitor class of drugs, offering patients an effective option for managing type 2 diabetes. While its market performance has been strong in Japan and China, it faces intense competition from established brands like dapagliflozin and empagliflozin. As the drug’s patents begin to expire, generic versions may enter the market, further affecting its market share. However, with ongoing clinical trials and potential for broader indications, Ipragliflozin remains a critical component of Astellas Pharma’s diabetes treatment portfolio.
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