Authorized Generics In The US: Prevalence, Characteristics, And Timing, 2010-19.

Abstract

Authorized generics are approved brand-name drugs that are sold by brand-name manufacturers or licensees without brands on their labeling. Despite their prevalence in prescription drug markets in the US, little is known about trends in their launches, their timing relative to traditional generics, and the characteristics of their respective brand-name drugs. We linked Food and Drug Administration and IQVIA data to investigate newly launched authorized generics during the period 2010-19. We found 854 launches over this period, with launches peaking in 2014. Marketing appears strategic: In markets with traditional generics, three-fourths of authorized generics launched after the respective generic competition started. When we focused on markets where generics were eligible for the 180-day exclusivity, about 70percent of authorized generics launched before or during the exclusivity period. These findings provide insights for future research on the effect of authorized generics on competition, prices, and access to generics.