Research Brief Summary:

The U.S. healthcare system continues to face persistent drug shortages, particularly affecting generic medications and sterile injectables. As of June 2024, the FDA reported 102 active shortages, with over half lasting more than two years. The gap between FDA approval of generics through Abbreviated New Drug Applications (ANDAs) and their actual market launch can further impact how quickly these drug shortages are addressed. This research brief assesses the launch status of approved generics as a whole and specifically, for those that are undergoing shortages. The brief also highlights the barriers that can prevent approved generics from launching, potentially leading to a longer time for the addressal of drug shortages.

Key Findings:

• Between 2013 and Q1 2024, 37% of approved generics had not launched, and it often takes over four years for 70% of generics to reach the market.
• For drugs currently under shortage, 62% have approved generics, yet 84% of these have at least one unlaunched product, and 21% have no generics launched at all.
• Injectables are disproportionately affected, with 75% of drug shortages involving unlaunched generics in this form.
• Company size also influences launch behavior. Smaller generic companies (those companies with less than $500Mn in annual global sales) which account for over half of all generic approvals since 2013, are more likely to launch generics than large or mid-sized firms. Smaller generic companies (<$500Mn) also respond more actively to drug shortages by launching approved generics.