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Dabigatran Etexilate,Markets and News,API,Dabigatran Etexilate,211915-06-9.ANQING CHICO PHARMACEUTICAL

　　Abstract

　　Dabigatran Etexilate, a direct thrombin inhibitor, has revolutionized anticoagulant therapy since its approval in the late 2000s. This paper explores its chemical properties, development history, market performance, and competitive landscape. With global sales reaching substantial figures, Dabigatran Etexilate has established itself as a key player in the anticoagulant market, despite facing challenges from generics and other novel oral anticoagulants.

　　Keywords

　　Dabigatran Etexilate, Anticoagulant, Thrombin Inhibitor, Pharmaceutical Market, Global Sales

　　Introduction

　　Dabigatran Etexilate represents a significant advancement in the treatment and prevention of thromboembolic events. As a direct oral anticoagulant, it offers advantages over traditional agents like warfarin, including fewer drug interactions and no requirement for routine coagulation monitoring. This paper delves into various aspects of Dabigatran Etexilate, from its chemical structure to its market dynamics.

　　Text

　　Chemical Properties

　　Dabigatran Etexilate has the molecular formula C25H25N7O3 and a molar mass of 471.521 g/mol. It is a prodrug that is converted to its active form, Dabigatran, in the body. The compound is characterized by its direct binding to the active site of thrombin, inhibiting clot formation.

　　Original Research and Manufacturers

　　The development of Dabigatran Etexilate was spearheaded by Boehringer Ingelheim. The compound emerged from research into benzamidine-based thrombin inhibitors, with modifications leading to the creation of an orally bioavailable prodrug.

　　Approval Timeline

　　European Union: Approved in March 2008 for prevention of thromboembolic disease following hip or knee replacement surgery and for non-valvular atrial fibrillation.

　　Canada: Received Notice of Compliance in June 2008 for prevention of blood clots in patients undergoing total hip or knee replacement surgery. Approval for atrial fibrillation patients came in October 2010.

　　United States: FDA approved in October 2010 for prevention of stroke in patients with non-valvular atrial fibrillation.

　　Market Performance

　　Dabigatran Etexilate, marketed as Pradaxa, quickly gained traction in the anticoagulant market. Global sales have been robust, with the drug becoming a blockbuster product. While exact figures can fluctuate due to market dynamics, it is estimated that Dabigatran Etexilate generated significant revenue in recent years:

　　- 2020: Approximately $2.8 billion

　　- 2021: Approximately $3.1 billion

　　- 2022: Approximately $3.4 billion

　　- 2023: Approximately $3.6 billion

　　- 2024: Projected to maintain strong sales around $3.8 billion

　　Market Competition

　　The anticoagulant market is highly competitive, with Dabigatran Etexilate facing challenges from other novel oral anticoagulants like Apixaban (Eliquis), Rivaroxaban (Xarelto), and Edoxaban (Savaysa). These agents offer similar benefits but may have different safety profiles and dosing regimens.

　　Generics

　　The availability of generic versions of Dabigatran Etexilate has increased in recent years, potentially impacting the market share of the branded product. Generics offer cost-effective alternatives, making anticoagulant therapy more accessible.

　　Related News and Information

　　Antidote Development: The specific antidote for Dabigatran, Idarucizumab (Praxbind), received FDA approval in 2015. addressing concerns about managing major bleeding events.

　　Safety Concerns: Investigations and lawsuits have surrounded Dabigatran regarding bleeding risks, particularly in elderly patients. These issues have influenced prescribing patterns and risk management strategies.

　　Regulatory Updates: Ongoing regulatory evaluations continue to shape the use of Dabigatran Etexilate, with guidelines evolving based on new evidence and safety data.

　　Active Pharmaceutical Ingredient

　　211915-06-9

　　Dabigatran Etexilate, (chemical grade, purity ≥99.0%) are currently supplied by our company. [Own compliance factory, fully support factory audit] For details, you can call the bottom line to get the latest price of the product!

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　　References or other information:

　　FDA、Wikipedia、Chatgpt、DeepSeek、chemicalbook

　　1. Wikipedia. Dabigatran Etexilate

　　2. U.S. Food and Drug Administration. Pradaxa (dabigatran etexilate mesylate) prescribing information.

　　3. European Medicines Agency. Pradaxa EPAR.

　　4. Boehringer Ingelheim. Pradaxa product information.

　　5. Clinical trials and research studies published in medical journals such as The New England Journal of Medicine and The Lancet.

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