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. 2023 Aug 3:11:1120729.
doi: 10.3389/fpubh.2023.1120729. eCollection 2023.

Does the first generic exclusivity system provide an economic incentive for early generic entrance under the patent linkage system?

Kyung-Bok Son  1
Affiliations

Does the first generic exclusivity system provide an economic incentive for early generic entrance under the patent linkage system?

Kyung-Bok Son. Front Public Health. .

Abstract

Introduction: A period of exclusivity for the first generics, as part of the patent linkage system, was established in South Korea to provide an economic incentive for early generic entry. This study describes the dynamics of generic penetration and assesses the first mover market share advantages under the patent linkage system.

Methods: Pairs of originators and their corresponding generics granted the first generic exclusivity from 2015 to 2020 were identified. We categorized generics into first movers and latecomers, described the penetration curves of generics, and estimated the saturated market share of generics, first movers, and latecomers. Volume-based monthly prescriptions were used to describe the generics' penetration curves. A logistic growth model was adopted to estimate the saturated market shares of generics.

Results: We identified 28 pairs of originators and generics, presented penetration curves, and estimated generics market shares. The saturated market share of generics was 30%, and the time to saturation was approximately 33 months. The shapes of penetration varied by nationality, route, and number of generics. The existence of latecomers was associated with the decreased penetration speed over time and decreased market share of generics. However, the first mover market share advantages or latecomers' disadvantages were consistently observed.

Conclusion: The generic uptake in South Korea is delayed, limited, and context-dependent. However, first generics' market share advantage suggests that a period of exclusivity, as part of the patent linkage system, could provide an economic incentive for early generic entrance.

Keywords: South Korea; first generic exclusivity; incentive for early generic entry; patent linkage system; pharmaceutical market.

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Conflict of interest statement

The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Generic penetration curves for all originator-generic pairs—pairs without and with latecomers. Note: The horizontal line in green indicates the estimated market share of generics using a logistic growth model.
Figure 2
Figure 2
Generic penetration curves separated by nationality, a route, and number of generics. Note: The horizontal line in green indicates the estimated market share of generics using a logistic growth model.
See this image and copyright information in PMC

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