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AuthorFatokun, O.
AuthorIbrahim, Mohamed Izham Mohamed
AuthorHassali, M.A.
Available date2022-04-10T10:25:37Z
Publication Date2013
Publication NameJournal of Generic Medicines
ResourceScopus
Identifierhttp://dx.doi.org/10.1177/1741134313483749
URIhttp://hdl.handle.net/10576/29449
AbstractMalaysia is reliant on the availability of generic medicines to contain the rising national pharmaceutical expenditure. 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 prevalidated 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 majorfactors 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 = -2.36, p = 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 recommended in order to meet the policy objectives of drug affordability and containment of pharmaceutical cost.
Languageen
SubjectBarriers
Generic entry
Generic medicines
Malaysia
Patent expiration
TitleFactors determining the post-patent entry of generic medicines in Malaysia: A survey of the Malaysian generic pharmaceutical industry
TypeArticle
Pagination22-33
Issue Number1
Volume Number10
dc.accessType Abstract Only


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