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Title: Pharmaceutical Business Strategy: A Generics Perspective
Authors: Thakur, Vikram Pratap Singh
Ramacha, Supriya
Keywords: Pharmaceutical business strategy
Generic drug launches
Patent and exclusivity expiries
Issue Date: Sep-2012
Publisher: NISCAIR-CSIR, India
Abstract: With most blockbuster drug patents facing patent expiries, there is the threat of generic equivalents pervading and diluting the innovator market. This patent cliff is not only making the market more attractive to the established generic drug makers, but is also inviting innovators’ interest in generic expansion. This article discusses the generic product entry routes in different jurisdictions (US, Europe and India) in the light of the nuances in legal provisions. It focuses on the various levels available for the entry of generic drug products such as safe entry, at-risk entry or by exploring licensing options. The article further discusses some strategies employed by innovator companies in order to extend the commercial benefit over a drug even beyond the term of the patent or related exclusivity. It discusses various business tactics employed by innovator companies such as development of follow-on drugs, creation of patent clusters, authorized generics, extensive branding and marketing, which help to delay or disincentivise the generic drug launch.
Description: 484-496
ISSN: 0975-1076 (Online); 0971-7544 (Print)
Appears in Collections:JIPR Vol.17(5) [September 2012]

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