Market Exclusivity and Changes in Competition and Prices Associated With the US Food and Drug Administration Unapproved Drug Initiative

In 2006, the US Food and Drug Administration (FDA) launched the Unapproved Drug Initiative (UDI) to document supporting data for several thousand drugs that had remained on the US market continually since before the agency began reviewing safety and effectiveness in 1938. 1 As an incentive, the FDA offered market exclusivity to the first manufacturer to receive approval of a legacy drug.In the short term, these market exclusivity periods drove up drug prices, most notably for the antigout drug colchicine.2,3 In November 2020, the FDA announced that the UDI program was ending, citing concerns that the program raised prices without generating new clinical data for most drugs.4 To assess the long-term effects of the UDI, we evaluated market exclusivity characteristics under the UDI program and how competition and prices changed 5 years after drug approval.