Understanding long-listed pharmaceutical products without competition in South Korea: policy implications in managing generic entrants and pharmaceutical expenditures.

Background: The nature of competition within the pharmaceutical sector has received a great deal of attention from policymakers and researchers. This is the first study to comprehensively analyze long listed single-source products within the South Korean market.Methods: Long listed single-source products are defined as pharmaceutical drugs that are available in the market for at least 8 years, without competition. We analyzed the determinants that lead to long listed single-source products in the market, and then evaluated their impact on health systems by examining the subsequent price responses of manufacturers.Results: Based on the number of drugs and their market values, pharmaceuticals categorized as long listed single-source products constitute a substantial portion of the market. Characteristics of the market are closely associated with generic entrants. In particular, the market size of a substance is associated with generic entrants, while the price of a brand-name drug is related to being long listed single-source products.Conclusions: Our analysis supports the creation of a regulatory and/or reimbursement system in order to support robust and effective competition within the marketplace. The first step toward rationalizing the system is to provide widespread information on drugs with limited competition or no competition.