All research-based pharmaceutical companies have to cope with the expiry of the patents protecting their biggest products. The 80% decline in sales of Eli Lilly’s Prozac within months of generic competitors entering the market in late 2001 was an indication of the damage that can be done when a drug’s market exclusivity is lost. Many companies are facing a similar meltdown in the sales of certain major products over the next few years. By 2009, all major cardiovascular drug classes will be genericised, thus potentially commoditising the largest and most lucrative therapy area.
Although the impact is greatest in the US, recent regulatory changes in previously ungenericised European markets such as France have ensured that companies have to deal with this threat in almost every major territory. It is no longer sufficient to begin efforts to extend a product’s lifecycle as patent expiry looms. Companies need to be developing a strategy to combat patent expiry even before a product is launched. There are many potential strategies to follow, and the choice depends on the particular circumstances of the product; second-generation versions with improved safety or efficacy, new formulations, combination products, licensed generics, and Over-the-counter (OTC) switching, are all potential choices.
Companies must be able to estimate the potential value of any investment in one or more of these brand protection strategies. The answer to this question will depend on the company’s corporate strategy, capabilities, resources and pipeline, and an understanding of brand and market specific factors will also be critical. The identification and implementation of lifecycle management and portfolio planning processes, tools and organisational structures will provide a strong foundation, enabling companies to confidently plan for generic competition.
How PricewaterhouseCoopers Can Help You
PricewaterhouseCoopers' specialists help address complex, sensitive, and risky investments in product development and lifecycle management to realise greater value through improved intellectual asset management. Our Valuation & Strategy practice has developed a proven approach that predicts how physicians and patients will respond to different brand strategies in a wide range of future scenarios. This provides decision-makers with detailed demand and forecasting analysis to make profitable and defensible decisions on brand investments. Once a strategy has been agreed and is being implemented, PricewaterhouseCoopers’ change management solutions range from identifying competency and skills gaps, to designing and delivering learning and knowledge-based solutions. As with any initiative which requires the support and buy-in of the workforce, effective employee communications are essential. Our Human Resource Service (HRS) professionals help companies with all aspects of employee communication and internal brand building to help ensure success.
