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Table 1 Count of post-approval new indications per drug

From: Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997

Count of new indications per drug 3-year new indication exclusivities 7-year new rare disease indication exclusivities Total
Drugs with 1 new indication 29 (83%) 6 (17%) 35 (100%)
Drugs with 2 new indications 32 (84%) 6 (16%) 38 (100%)
Drugs with 3 or more new indications 37 (86%) 6 (33%) 43 (100%)
Total 98 (84%) 18 (16%) 116 (100%)
  1. Over the 23-year observation period, the cohort of drugs for which generic entry was observed had a total of 116 new indications added during the post-approval period collectively. The majority were for common diseases, rather than for rare diseases, despite the difference in their duration (i.e., 3 versus 7 years, respectively). 70% (38 + 43 = 81) of the new indications were not the first new indication added for that same drug (i.e., they were the second, third, or even the fourth new indication added during the post market period). This may imply that some drug innovators are much more active than others in seeking out new indications