Fig. 1

Probability of new indication exclusivity granted by FDA for drugs approved, 1997–2020. The probability of a new indication addition is highest when NMEs have been relatively recently (within 1–2 years) and when generic entry is around 7–8 years into the future. The probability is lowest when an NME has been approved for more than 15 years and when generic entry has already occurred. “Age (in years)” = number of years since FDA approval