Market exclusivity of the originator drugs in South Korea: A retrospective cohort study
- Title
- Market exclusivity of the originator drugs in South Korea: A retrospective cohort study
- Author
- 손경복
- Keywords
- pharmaceutical expenditure; the first generic; market competition; market exclusivity; South Korea; Public aspects of medicine; RA1-1270
- Issue Date
- 2021-04
- Publisher
- FRONTIERS MEDIA SA
- Citation
- Frontiers in Public Health, Vol 9 (2021)
- 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 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.
- URI
- https://doaj.org/article/09a8510b25ed4f99b11f6958f5bf64aehttps://repository.hanyang.ac.kr/handle/20.500.11754/171754
- ISSN
- 2296-2565
- DOI
- 10.3389/fpubh.2021.654952
- Appears in Collections:
- COLLEGE OF PHARMACY[E](약학대학) > PHARMACY(약학과) > Articles
- Files in This Item:
There are no files associated with this item.
- Export
- RIS (EndNote)
- XLS (Excel)
- XML