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

• Main Author: Kyung-Bok Son (Author)
• Format: Book
• Published: Frontiers Media S.A., 2021-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

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 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.Conclusion: 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.

Item Description

2296-2565
10.3389/fpubh.2021.654952