Market dynamics of authorized generics in Medicaid from 2014 to 2020

Abstract

Objective To investigate the use and timing of market introduction of authorized generics (AGs), which unlike independent generics are sold by the brand‐name drug manufacturer under a generic label. Data Sources This study used public Medicaid prescription drug use data from 2014 to 2020. Study Design This cross‐sectional study measured the percentage of filled prescriptions for AGs, compared with brand‐name and independent generic versions. We also identified the frequency and characteristics of AGs marketed at least 1 year before independent generics. Data Extraction Methods Drugs were classified based on manufacturer‐reported data to Medicaid. Principal Findings From 2014 to 2020, 1023 AGs accounted for 175 million filled Medicaid prescriptions. These represented 4% of Medicaid prescription drug use, and 16% of medication use among products with AGs available. Among 393 AGs for drugs without generic competition before 2014, 139 (35%) were marketed at least 1 year before independent generics or had no independent generic competition through December 2020. Conclusions AGs represented a small share of Medicaid prescription drug use from 2014 to 2020, but when AGs were available, they accounted for sizeable market share. Among the minority of cases in which AGs were marketed a year or more before independent generics, manufacturers may be using AGs to bolster brand‐name drug prices or to undermine independent generic competition, meriting further attention by regulators.