AUTHOR=Son Kyung-Bok 

TITLE=Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study

JOURNAL=Frontiers in Public Health

VOLUME=9

YEAR=2021

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2021.654952

DOI=10.3389/fpubh.2021.654952

ISSN=2296-2565

ABSTRACT=<p><bold>Introduction:</bold> Generic entry is a well-known driver of competition and cost containment.</p><p><bold>Objectives:</bold> We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea.</p><p><bold>Methods:</bold> A list of originator drugs approved by the authority from 2000 to 2013 and their corresponding generics were paired. An event history model was applied for a statistical estimation for the duration until generic entry and to identify abbreviating or prolonging factors on the duration.</p><p><bold>Results:</bold> A total of 2,061 pairs of originator and generics were identified. The market exclusivity for the originator drugs, including NDAs and non-NDAs, has not notably changed. However, competition among non-NDAs was less common than we expected. We found delayed time to entry of generics in the long run, particularly for non-NDAs in injection forms and biologics, and this finding is partially associated with market attractiveness.</p><p><bold>Conclusion:</bold> The authority should address the delayed availability of certain types of generic drugs. The government could provide information on off-patent pharmaceuticals with no generic competition, designate their corresponding submissions as prioritized in the review process, and provide additional market exclusivity when entering the market via a long period of exclusivity.</p>