New Drug Formulations and Their Respective Generic Entry Dates

Among 17 new small-molecule drugs approved in 2002, manufacturers introduced new formulations in 53% of cases, and generic entry for new formulations occurred more than 2 years later than the original product in one-third of cases where generics were available. These findings suggest that new drug formulations can provide manufacturers with substantial additional periods of market exclusivity beyond the original product’s patent protection, potentially delaying generic competition and affecting access to affordable alternatives.