Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market

The Malaysia healthcare system relies on the availability of generic equivalents of innovator medicines to curtail the rising pharmaceutical expenditure. This study assesses the dimensions and dynamics of generic medicines entry following patent expiration on the innovator drug products in Malaysia....

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Main Author:	Fatokun, Omotayo Oladuntoye
Format:	Thesis
Language:	English
Published:	2014
Subjects:	RS1-441 Pharmacy and materia medica
Online Access:	http://eprints.usm.my/46094/1/Fatokun%20Omotayo%20Oladuntoye24.pdf
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id	my-usm-ep.46094
record_format	uketd_dc
spelling	my-usm-ep.460942020-02-05T08:13:43Z Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market 2014-02 Fatokun, Omotayo Oladuntoye RS1-441 Pharmacy and materia medica The Malaysia healthcare system relies on the availability of generic equivalents of innovator medicines to curtail the rising pharmaceutical expenditure. This study assesses the dimensions and dynamics of generic medicines entry following patent expiration on the innovator drug products in Malaysia. This was a mixed-methods study. The findings of this research revealed 14 categories of policies and regulatory measures with varying effects on generic entry in Malaysia. The mail survey yielded a usable response rate of 53.8% (14/26) following four successive mailings. Reliability coefficients for the multi-item entry decisions and entry barriers variables were 0.62 and 0.82 respectively. The major factors driving generic development and entry decisions in Malaysia were pre-patent expiration market value of innovator’s products (Meanrank= 3.75, M=4.14, SD=1.03), cost of generic development and approval (Mean-rank= 3.04, M=3.50, SD=1.40) and compatibility of the new generic medicine with firms’ existing products range (Mean-rank=2.79, M=3.64, SD=1.2). The innovator product’s pre-patent expiration market value was a significant entry driver for domestic-market oriented generic firms as compared with export-market oriented firms (U=0.00, Z=- 2.36, p=0.01). The Major barriers to generic medicines development and market entry in Malaysia were patent clustering by innovator firms (Mean-rank=7.96, M=4.07, SD=0.83) and earlier market entry of imported generics (Mean-rank=7.75, M=4.07, SD=0.73). 2014-02 Thesis http://eprints.usm.my/46094/ http://eprints.usm.my/46094/1/Fatokun%20Omotayo%20Oladuntoye24.pdf application/pdf en public phd doctoral Universiti Sains Malaysia Pusat Pengajian Sains Farmasi
institution	Universiti Sains Malaysia
collection	USM Institutional Repository
language	English
topic	RS1-441 Pharmacy and materia medica
spellingShingle	RS1-441 Pharmacy and materia medica Fatokun, Omotayo Oladuntoye Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market
description	The Malaysia healthcare system relies on the availability of generic equivalents of innovator medicines to curtail the rising pharmaceutical expenditure. This study assesses the dimensions and dynamics of generic medicines entry following patent expiration on the innovator drug products in Malaysia. This was a mixed-methods study. The findings of this research revealed 14 categories of policies and regulatory measures with varying effects on generic entry in Malaysia. The mail survey yielded a usable response rate of 53.8% (14/26) following four successive mailings. Reliability coefficients for the multi-item entry decisions and entry barriers variables were 0.62 and 0.82 respectively. The major factors driving generic development and entry decisions in Malaysia were pre-patent expiration market value of innovator’s products (Meanrank= 3.75, M=4.14, SD=1.03), cost of generic development and approval (Mean-rank= 3.04, M=3.50, SD=1.40) and compatibility of the new generic medicine with firms’ existing products range (Mean-rank=2.79, M=3.64, SD=1.2). The innovator product’s pre-patent expiration market value was a significant entry driver for domestic-market oriented generic firms as compared with export-market oriented firms (U=0.00, Z=- 2.36, p=0.01). The Major barriers to generic medicines development and market entry in Malaysia were patent clustering by innovator firms (Mean-rank=7.96, M=4.07, SD=0.83) and earlier market entry of imported generics (Mean-rank=7.75, M=4.07, SD=0.73).
format	Thesis
qualification_name	Doctor of Philosophy (PhD.)
qualification_level	Doctorate
author	Fatokun, Omotayo Oladuntoye
author_facet	Fatokun, Omotayo Oladuntoye
author_sort	Fatokun, Omotayo Oladuntoye
title	Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market
title_short	Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market
title_full	Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market
title_fullStr	Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market
title_full_unstemmed	Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market
title_sort	assessment of policies, determinants and characteristics of generic medicines entry into the malaysian pharmaceutical market
granting_institution	Universiti Sains Malaysia
granting_department	Pusat Pengajian Sains Farmasi
publishDate	2014
url	http://eprints.usm.my/46094/1/Fatokun%20Omotayo%20Oladuntoye24.pdf
_version_	1747821609202221056

Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market

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