Association between US Pharmacopeia (USP) monograph standards, generic entry and prescription drug costs

Autoři: Irene B. Murimi-Worstell aff001;  Jeromie M. Ballreich aff002;  Marissa J. Seamans aff002;  G. Caleb Alexander aff001
Působiště autorů: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America aff001;  Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, Maryland, United States of America aff002;  Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America aff003;  Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America aff004;  Division of General Internal Medicine, Department of Medicine, Johns Hopkins Medicine, Baltimore, Maryland, United States of America aff005
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0225109


Despite the importance of pharmacopeial standards, little is known regarding their effect on drug competition. Such information is of particular relevance given the rising costs of prescription drugs and the focus of policy-makers and other stakeholders on addressing these costs. We examined 982 prescription drugs approved by U.S Food and Drug Administration since 1982 to examine the association between U.S. Pharmacopeia (USP) standards, generic entry and prescription costs. The presence of a USP drug product monograph was not associated with the time to the third generic entrant or with the likelihood of having a generic competitor. However, on average, drugs with USP drug product monographs had approximately fifty percent more generic manufacturers in the U.S. than their counterparts after accounting for factors such as market volume, age, route of administration and vintage. This greater competition was associated with an approximate savings of $6.22 billion in 2016, suggesting that USP drug product monographs may play an important role in promoting pharmaceutical competition and reducing prescription drug costs.

Klíčová slova:

Drug administration – Drug discovery – Drug information – Drug research and development – Drug screening – Drug users – Routes of administration – Drug marketing


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Článek vyšel v časopise


2019 Číslo 11