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Fig. 3 | Journal of Pharmaceutical Policy and Practice

Fig. 3

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

Fig. 3

Predicted conditional probability of a new indication exclusivity approval. When we applied the strongest observed influence of generic entry (i.e., generic entry had already occurred [\({\beta }_{1}\)]) to all NMEs, shown in black is our model’s predicted probability of new indications additions, which is near zero, regardless of the age of the drug. Note that by law, generic entry cannot occur in the United States prior to 5 years after FDA approval when the product in question is designated as a small-molecule NME, and therefore, the black line begins only after 5 years accordingly. When we applied the weakest observed influence of generic entry (i.e., generic entry is 5–10 years into the future [\({\beta }_{3}\)]) to all NMEs, shown in red is our model’s predicted probability of new indications additions, which is substantially higher, regardless of the age of the drug

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Journal of Pharmaceutical Policy and Practice

ISSN: 2052-3211

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