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

References

• Fischer KE, Stargardt T. The diffusion of generics after patent expiry in Germany. Eur J Health Econ. 2016;17(8):1027–1040.
   PubMed Web of Science ®Google Scholar
• Kanavos P, Costa-Font J, Seeley E. Competition in off-patent drug markets: issues, regulation and evidence. Econ Policy. 2008;23(55):500–544.
   Google Scholar
• Gupta R, Shah ND, Ross JS. Generic drugs in the United States: policies to address pricing and competition. Clin Pharmacol Ther. 2019;105(2):329–337.
   PubMed Web of Science ®Google Scholar
• Darrow JJ, Kesselheim AS. Promoting competition to address pharmaceutical prices. Health Affairs, Prescription Drug Pricing. 2018 March;15:57–65.
   Google Scholar
• Guo JJ, Kelton CM. Competition between brand-name and generic drugs. Handbook of pharmaceutical public policy. New York: Haworth Press, Inc; 2007. p. 395–416.
   Google Scholar
• Li DG, Joyce C, Mostaghimi A. Association between market competition and prices of generic topical dermatology drugs. JAMA Dermatol. 2018;154(12):1441–1446.
   PubMed Web of Science ®Google Scholar
• Alpern JD, Zhang L, Stauffer WM, et al. Trends in pricing and generic competition within the oral antibiotic drug market in the United States. Clinl Infect Dis. 2017;65(11):1848–1852.
   PubMed Web of Science ®Google Scholar
• Ngorsuraches S, Chaiyakan K. Equitable prices of single-source drugs in Thailand. Appl Health Econ Health Policy. 2015;13(4):389–397.
   PubMed Web of Science ®Google Scholar
• Alpern JD, Shahriar AA, Xi M, et al. Characteristics and price increases among sole-source, off-patent drugs in the United States, 2008 to 2018. JAMA Network Open. 2020;3(8):e2013595–e2013595.
   PubMed Web of Science ®Google Scholar
• Vokinger KN, Kesselheim AS, Avorn J, et al. Strategies that delay market entry of generic drugs. JAMA Intern Med. 2017;177(11):1665–1669.
   PubMed Web of Science ®Google Scholar
• Drake KM, Starr MA, McGuire TG. Do “reverse payment” settlements constitute an anticompetitive pay-for-delay? Int J Econ Bus. 2015;22(2):173–200.
   Web of Science ®Google Scholar
• Son K-B. Generic atorvastatin and rosuvastatin in the South Korean market: time of introduction in relation to manufacturer characteristics. Expert Rev Pharmacoecon Outcomes Res. 2020;20(5):541–548.
   PubMed Web of Science ®Google Scholar
• Korea Pharmaceutical and Bio-Pharma Manufacturers Association. Pharmaceutical Industry databook. Seoul: Korea Pharmaceutical and Bio-Pharma Manufacturers Association; 2019.
   Google Scholar
• Korea Health Industry Development Institute. Pharmaceutical industry analysis report. Chungbuk: Korea Health Industry Development Institute; 2017.
   Google Scholar
• Son K-B. Is greater generic competition also linked to lower drug prices in South Korea? Health Econ Rev. 2020;10(1):1–9.
   PubMed Web of Science ®Google Scholar
• Jang S, Byun J, Song I, et al. PPRI pharma profile South Korea 2018. In: PPRI, editors. Pharmaceutical pricing and reimbursement information (PPRI). Incheon: College of Pharmacy, Gachon University; 2019.
   Google Scholar
• Hemphill CS, Sampat BN. When do generics challenge drug patents? J Empir Leg Stud. 2011;8(4):613–649.
   Web of Science ®Google Scholar
• Kim L, Kim J-A, Kim S. A guide for the utilization of health insurance review and assessment service national patient samples. Epidemiol Health. 2014;36:e2014008.
   Google Scholar
• Kim L, Sakong J, Kim Y, et al. Developing the inpatient sample for the national health insurance claims data. Health Policy Manage. 2013;23(2):152–161.
   Google Scholar
• Morton FS, Boller LT Enabling competition in pharmaceutical markets. Brookings, Brookings. 2017;2.
   Google Scholar
• Hemphill TA. Generic drug competition: the pharmaceutical industry “gaming” controversy. Bus Soc Rev. 2019;124(4):467–477.
   Web of Science ®Google Scholar
• Lexchin J. The effect of generic competition on the price of brand-name drugs. Health Policy. 2004;68(1):47–54.
   PubMed Web of Science ®Google Scholar
• Grabowski H, Long G, Mortimer R, et al. Updated trends in US brand-name and generic drug competition. J Med Econ. 2016;19(9):836–844.
   PubMed Web of Science ®Google Scholar
• Hernandez I, San-Juan-Rodriguez A, Good CB, et al. Changes in list prices, net prices, and discounts for branded drugs in the US, 2007-2018. Jama. 2020;323(9):854–862.
   PubMed Web of Science ®Google Scholar
• Dental and Phamaceutical Benefits Agency. International price comparison of pharmaceuticals 2017. Stockholm: Dental and Phamaceutical Benefits Agency; 2017.
   Google Scholar
• Park J, Bae S, Lee T-J, et al. Marketing and pricing strategies of blockbuster drugs in the South Korean market: a 15-year retrospective cohort study for choline alfoscerate. Front Pharmacol. 2020;11(232).
   Web of Science ®Google Scholar
• Porath D. Size and dynamics of order-of-entry effects in pharmaceutical markets. Int J Market Res. 2018;60(1):50–66.
   Web of Science ®Google Scholar
• Frank RG, Salkever DS. Generic entry and the pricing of pharmaceuticals. J Econ Manage Strategy. 1997;6(1):75–90.
   Web of Science ®Google Scholar
• Miller BM. Product hopping: monopolization or innovation. BUJ Sci & Tech L. 2016;22:89.
   Google Scholar
• Dalen DM, Strøm S, Haabeth T. Price regulation and generic competition in the pharmaceutical market. Eur J Health Econ. 2006;7(3):204–211.
   Google Scholar
• Dave CV, Kesselheim AS, Fox ER, et al. High generic drug prices and market competition: a retrospective cohort study. Ann Intern Med. 2017;167(3):145–151.
   PubMed Web of Science ®Google Scholar
• Simoens S. A review of generic medicine pricing in Europe. GaBI J. 2012;1(1):8–12.
   Google Scholar
• Hernandez I. Substantial” increases in list and net prices of branded drugs in the US. PharmacoEcon Outcomes News. 2020;849:2–21.
   Google Scholar
• Hemphill TA. Extraordinary pricing of orphan drugs: is it a socially responsible strategy for the US pharmaceutical industry? J Bus Ethics. 2010;94(2):225–242.
   Web of Science ®Google Scholar
• Regulatory Focus. FDA to speed reviews of more generic drugs, offers lists of those with no competition 2017. [cited 2020 Jul 7]. Available from: https://www.raps.org/regulatory-focus™/news-articles/2017/6/fda-to-speed-reviews-of-more-generic-drugs,-offers-lists-of-those-with-no-competition
   Google Scholar
• Toufanian M, Peters JR, Uhl K. Prioritization of generic drug review. JAMA Intern Med. 2017;177(1):140–141.
   PubMed Web of Science ®Google Scholar
• Regulatory Focus. FDA updates list of drugs without generic competition 2018 [cited 2020 Jul 7]. Available from: https://www.raps.org/regulatory-focus™/news-articles/2017/6/fda-to-speed-reviews-of-more-generic-drugs,-offers-lists-of-those-with-no-competition
   Google Scholar
• Darrow J, Kesselheim AS. Promoting competition to address pharmaceutical prices. Health Affairs. 2018 Mar 15.
   Google Scholar
• Johansen ME, Richardson C. Estimation of potential savings through therapeutic substitution. JAMA Intern Med. 2016;176(6):769–775.
   PubMed Web of Science ®Google Scholar
• Duru OK, Ettner SL, Turk N, et al. Potential savings associated with drug substitution in medicare part D: the translating research into action for diabetes (TRIAD) study. J Gen Intern Med. 2014;29(1):230–236.
   PubMed Web of Science ®Google Scholar
• McCarthy M. Therapeutic substitution could reduce US drug spending by nearly 10%, study finds. BMJ. 2016;;353:i2710.
   Google Scholar