We examined data on the entry rates of second and later entrants in 43 pharmacologic classes, as well as the timing of patent filings and development milestones for 79 later-in-class drugs. The median time to when a second entrant was approved was 2.7 years. A substantial majority of later-in-class drugs had a patent filed and were in clinical development prior to the approval of the first-in-class drug.
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DiMasi et al. (2016) studied this question.
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