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

ABSTRACT: Introduction: Generic entry is a well-known driver of competition and cost containment. Objectives: We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea. Methods: 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. Results: 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 expect

SUBMITTER: Son KB 

PROVIDER: S-EPMC8056004 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature