Exclusive Summary

• Dapoxetine's patent has expired, opening up a vast global generic market for the only FDA and EMA-approved oral treatment for premature ejaculation, addressing an urgent market need.
• Premature ejaculation affects approximately 30% of adult males globally, representing a significant disease burden and largely unmet medical need, indicating a huge market potential.
• Dapoxetine demonstrates proven clinical efficacy and is recommended as a first-line treatment for PE in various guidelines, establishing its clear therapeutic position.
• Chinese suppliers can offer competitively priced generics due to large-scale production and cost advantages, particularly appealing to markets seeking cost-effective solutions and in emerging economies.
• Adherence to high-quality manufacturing standards and experience in international regulatory affairs are crucial for accessing major global markets, enhancing partnership attractiveness.