When drugs reach their patent terminations, generic producers typically enter the market with products mostly far low-priced than the original. This is the so-called “patent Precipice”. This places Pharma companies in a difficult position due to huge expenses on R&D, possibly permanent costs, and the potential to lose up to 90 per cent of their sales. However, companies can adopt methods to maximise the time to commercialise a drug within the patent protection period and perform life cycle management strategies that enable business sustainability for a drug well beyond its patent cliff. The need to obtain a significant return on investment within the patent safety period .The Food and Drug Administration (FDA) normally grants a patent for 20 years. While this may seem like a long period in which to gain a significant return on investment (ROI), it is important to remember that it can take from 8 to 12 years to gain FDA approval. One example of this lengthy process is that, according to US Federal Law, an appropriate marketing application must be obtained before a drug can even be trialled or circulated across state lines. This means that clinical trials in other states, exclusively orphan drugs for rare diseases where it is hard to find sufficient participants, require an exemption. For the launch process to be successful, managing for market access needs to begin when a Pharma company plans its first set of trials. Plotting a winning trajectory in the first year of launch can be achieved through planning from the initial stages through to market launch. Payer power has grown in recent years, and a robust end-to-end strategy is all the more significant for smaller companies with limited portfolios and slimmer margins. Large companies, with a diverse portfolio of products, can accept smaller returns and are better equipped to weather the paper storm in negotiations with payers. Early on, Pharma companies must prepare their policies to continually promote a product well beyond the patent expiration to help ensure market share and sustain revenue.
(*Excerpt taken from a conversation with David B. Sudzus, pharma-iq)
Global Market Analysis:
Over the last decade, industry’s productivity has been decreasing with rising R&D costs and time is taken to reach a market. Medicinal chemistry is defined as a focused science that is developed to cover a wide-ranging of fields related to identification, synthesis and drug development for therapeutic applications. This science has evolved from medical chemists focusing on drug target or pathway in mind and league of elaborative chemistry-driven processes to a modern generation of high-throughput screening (HTS) libraries that are formed by combinatorial chemistry based on limited structural distinctions across large drug like scaffolds.