Affordability and Availability of Off-Patent Drugs in the United States—The Case for Importing From Abroad: Observational Study

Among 170 off-patent drugs, 64% had at least one manufacturer approved by non-US regulatory agencies with similar standards to the FDA, and 48% of drugs without FDA-approved generics were available from non-US approved manufacturers. Facilitating US patient access to these internationally approved manufacturers could help address affordability and availability challenges for essential off-patent drugs, potentially saving Medicaid approximately $700 million annually on drugs lacking adequate domestic competition.