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See the DrugPatentWatch profile for Dabigatran
There isn’t any publicly disclosed figure for the exact production cost (cost of goods) to manufacture dabigatran etexilate. That kind of cost is commercial and varies by manufacturer, scale, and contractual details, so it isn’t usually published. What determines the production cost for a complex small-molecule prodrug like dabigatran etexilate: - Synthesis route complexity and number of steps - Overall yield per step and the final overall yield - Cost and availability of raw materials and reagents (including any specialized or chiral reagents) - Purification requirements and solvent/waste handling (GMP, QA/QC, stability testing) - Scale of production (pilot vs. commercial scale) and plant efficiencies - Regulatory/compliance costs, quality control, documentation, and packaging - Intellectual property and licensing costs (patents governing the route and use) - Facility and labor costs, energy, and waste management If you’re trying to estimate costs for a project, here are practical steps you can take: - Review patent literature and regulatory filings to understand the disclosed synthesis route and required purity. This helps you build a rough Bill of Materials (BOM). - Gather current price quotes for reagents and solvents from suppliers and estimate consumption per kilogram of API. - Estimate step-by-step yields and multiply to get overall API yield per kilogram of input materials. - Add in purification losses, solvent recycling, and waste treatment costs. - Factor GMP-related costs, QA/QC, analytical testing, packaging, and shelving stability studies. - Create a simple cost model (per kg of API) and then scale up to your desired production volume. If you’d like, I can help you outline a generic cost-model template or point you to patent sources that describe the synthetic route at a high level. If you have a target production scale, purity requirements, and region for manufacturing, I can tailor a rough budgeting framework for you.
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