Assessment of policies, determinants, and characteristics of generic medicines entry into the pharmaceutical markets

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Abstract

This chapter discusses the dimensions and determinants of postpatent entry of generic medicines into the pharmaceutical markets in developing countries. A variety of policies and regulatory measures relating to generic medicines entry are in place in developing countries. However, these policies are less robust, seem less coherent, and there are potential gaps between policy intent and implementation. The postpatent entry of generic medicines in developing countries is majorly determined by the prevailing regulatory policies and intellectual property rights, prepatent market size of the innovator products, generic firm's characteristics, and the existence and the degree of the entry-deterrence strategies by innovators, majority of which are derived from the patent system. Although the pattern of postpatent entry of generic medicines into the pharmaceutical markets in developing countries is similar to that in developed markets, the extent of generic entry and competition in developing countries appear limited.

Original languageEnglish
Title of host publicationSocial and Administrative Aspects of Pharmacy in Low-and Middle-Income Countries
Subtitle of host publicationPresent Challenges and Future Solutions
EditorsMohamed Izham Mohamed Ibrahim, Albert I. Wertheimer, Zaheer-Ud-Din Babar
Place of PublicationLondon UK
PublisherAcademic Press
Chapter13
Pages211-225
Number of pages15
Edition1st
ISBN (Electronic)9780128112298
ISBN (Print)9780128112281
DOIs
Publication statusPublished - 2018
Externally publishedYes

Keywords

  • Competition
  • Developing countries
  • Entry barriers
  • Generic medicines
  • Generic medicines policy
  • Market entry
  • Patents
  • Pharmaceuticals
  • Regulation

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