Full Title: Lifecycle Management Strategies: Maximizing ROI through indication expansion, reformulation and Rx-to-OTC switching Executive Summary When a branded product loses patent protection, bioequivalent generic versions of the original compound can be launched by competitors, invariably at a lower price; this leads to strong competition for the branded product, which then experiences declining sales and market share. It is not unusual for product sales to fall by 80% or more after patent expiration if generic competition is strong. Patent expiries are thus viewed with considerable apprehension by pharmaceutical companies, particularly if the affected products are major revenue drivers and/or blockbusters. To maximize product sales and minimize the impact of generic competition, drug developers may utilize a variety of options including indication expansion, reformulation, second generation launch, Rx-to-OTC switch, own generic launch and divestiture. However, each of these strategies has strengths and weaknesses, depending upon the characteristics of the product and its developer. Furthermore, various industry trends such as rising financial pressure on pharmaceutical companies, heightened regulatory scrutiny and increasing cost containment initiatives by health care payers are rendering certain strategies more favourable than others. This report examines the circumstances under which each strategy can provide benefits, when each strategy is limited, and cases when the strategy was used successfully and unsuccessfully. Pages: 163 Table of Contents Download TOC in PDF
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