“Enhancing Pharmaceutical Accessibility: Evaluating the Impact of Competitive Generic Therapy Exclusivity on Rapid Access of Generics into the U.S. Market (2019–2024)”

Abstract

The affordability and accessibility of generic medications drive their dominance in the U.S. market. Competitive Generic Therapy (CGT) exclusivity promotes efficient development, expedited market entry, and swift reviews for drugs with inadequate competition. This study examines CGT exclusivity approvals from January 2019 to October 2024, focusing on therapeutic areas with limited competition and the impact on patient access. Of 353 applications reviewed, 126 exclusivities granted from 2019 to 2023 were analysed. The average time to market was assessed, excluding 2024 due to unavailable marketing dates. One of the key findings of this study highlights the disparity in marketing timelines between generics approved for life-threatening versus non-serious conditions. While CGT-designated drugs for life-threatening conditions reach the market faster (21.53 days on average), those for non-serious conditions experience longer delays (29.56 days on average). External factors like market demand and competition risk greatly impact CGT exclusivity, driving manufacturers to prioritize critical therapies to trigger exclusivity while ensuring generic accessibility in the U.S. market. By analysing the landscape of CGT exclusivity approvals, this study emphasizes how these regulatory measures tackle areas of inadequate competition, thereby enabling quicker patient access to vital therapies. The research identifies how CGT exclusivity helps in rapid access to generic drugs in the U.S. market. In conclusion, this study underscores the effectiveness of CGT exclusivity in reducing time-to-market for generics, thereby improving accessibility and addressing gaps in competition. These insights emphasize the importance of regulatory measures like CGT exclusivity in promoting accessibility while addressing the broader challenges of generic competition.