Comparative analysis of FDA approvals by top 20 pharma companies (2014–2023)

•FDA approved 176 new drugs for the 20 leading pharmaceutical companies (2014–2023).•An additional 33 new drugs were acquired through post-approval acquisition (2014–2023).•Big pharma launched 83 first-in-class drugs (2014–2023).•Most new drugs of the top 20 pharma companies were approved in oncology.•Big pharma’s share of the industry’s R&D output declined from 72% (2014) to 40% (2023). This article addresses the research and development (R&D) productivity challenge of the pharmaceutical industry, focusing on United States Food and Drug Administration (FDA)-related new drug approvals of the top 20 pharmaceutical companies (2014–2023). We evaluated the degree of innovation in new drugs to determine the innovativeness of these leading companies. A key finding of our analysis is the decline in the number of new drugs approved by the FDA for these leading companies over the investigated time period. This trend suggests that some of the leading companies are losing ground in R&D innovation, raising concerns about their ability to sustain competitive advantage, ensure long-term market success, and maintain viable business models.