Original Paper Factors determining the post-patent entry of generic medicines in Malaysia: A survey of the Malaysian generic pharmaceutical industry Omotayo Fatokun 1,2 , Mohamed IM Ibrahim 3 and Mohamed A Hassali 1 Abstract Malaysia is reliant on the availability of generic medicines to contain the rising national pharmaceutical expend- iture. This paper assesses the factors determining the market entry of a new generic medicine following patent expiration on the innovator product in Malaysia. Data were gathered by using mail survey approach. The pre- validated Likert-scale questionnaire was mailed to all licensed members of the Malaysian Organization of Pharmaceutical Industries. A usable response rate of 53.8% (14/26) was achieved following four successive mailings. The overall internal reliability coefficients for the 5-item entry decision variables scale and 11-item entry barrier variables scale were 0.62 and 0.82 respectively. The results revealed that the major factors driving decisions to develop and introduce a new generic medicine into the Malaysian pharmaceutical market are consistent with the business model of the generic pharmaceutical industry. The pre-patent expiration market value of the innovator product was found to be a significant factor influencing entry decisions for domestic market-oriented generic firms as compared with export-oriented firms (Z ¼2.36, p ¼ 0.01). Foremost among the barriers to new generic medicines development and market introduction in Malaysia were patent clustering by innovator firms and the earlier market entry of imported generic medicines. There is a need for strict adherence to the patentability criteria in the examination and grant of pharmaceutical patents in Malaysia, and coherence in policies related to local generic drug development and production is recom- mended in order to meet the policy objectives of drug affordability and containment of pharmaceutical cost. Keywords Patent expiration, generic medicines, generic entry, barriers, Malaysia Introduction Malaysia relies on the availability of generic medicines following patent expiration on innovator products to contain the rising pharmaceutical expenditure in its highly subsidized public health care sector and reduce the burden on the out-of-pocket paying consumers in the private health care sector. 1,2 However, the possibil- ity of a generic medicine becoming available following patent expiration on the innovator product is depend- ent on various factors that a generic pharmaceutical firm has to take into consideration. Indeed, the entry decision process is complex. 3 The literature is replete with empirical discussions on several determinants and factors driving or impeding the entry of generic medi- cines. 3–9 Yet, in Malaysia, little has been reported on this phenomenon, despite the country’s strong patent protection system, proliferation of pharmaceutical patents and dependence on generics availability. 10–12 The literature indicates that post-patent entry of generic medicines is affected by the market character- istics, behaviour of innovator companies and the exist- ence of incentive structures that promote generic development and production by the generic indus- try. 4–6,8,13,14 In sum, the market entry of generic medi- cines following patent expiration is highly dependent 1 Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia 2 Faculty of Pharmaceutical Sciences, UCSI University, 56000 Kuala Lumpur, Malaysia 3 College of Pharmacy, Qatar University, Doha, Qatar Corresponding author: Omotayo Fatokun, Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia. Email: tayofatokun@gmail.com Journal of Generic Medicines 10(1) 22–33 ! The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1741134313483749 jgm.sagepub.com