What Product-Life Cycle Management Strategies Could Be Used To Extend The Life Of A Pharmaceutical Drug?

By David Watt, Technical Director in the Business Development Department, WellSpring

Name brand (Innovator) pharmaceutical companies must extend the product life cycles of drugs to maintain profits, exclusivity, market share and transition into next generation products. Patent protection is crucial to the innovative pharmaceutical industry. Innovative companies require the guaranteed period of market exclusivity to sustain drug prices, recoup research and development costs and to fund the development of new products or next generation drugs.

As with other inventions, pharmaceutical products are entitled to patent protection if they meet certain criteria. Unlike other products, drug products undergo a strict regime of test and evaluations to determine their safety, quality and efficacy before they can be distributed and sold commercially. The testing of new drug products is rigorous, costly and time consuming as lengthy clinical trials are required for new drug applications. Once the development work has been completed, the patent and new drug application can take a significant amount of time to be reviewed and ultimately approved or denied.